Cover
Cover - USD ($) | 12 Months Ended | ||
Dec. 31, 2022 | Mar. 16, 2023 | Jun. 30, 2022 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 31, 2022 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Transition Report | false | ||
Entity File Number | 001-36306 | ||
Entity Registrant Name | Eagle Pharmaceuticals, Inc. | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 20-8179278 | ||
Entity Address, Address Line One | 50 Tice Boulevard | ||
Entity Address, Address Line Two | Suite 315 | ||
Entity Address, City or Town | Woodcliff Lake | ||
Entity Address, State or Province | NJ | ||
Entity Address, Postal Zip Code | 07677 | ||
City Area Code | 201 | ||
Local Phone Number | 326-5300 | ||
Title of 12(b) Security | Common stock, $0.001 par value per share | ||
Trading Symbol | EGRX | ||
Security Exchange Name | NASDAQ | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Accelerated Filer | ||
Entity Small Business | false | ||
Entity Emerging Growth Company | false | ||
ICFR Auditor Attestation Flag | true | ||
Entity Shell Company | false | ||
Entity Public Float | $ 412,548,056 | ||
Entity Common Stock, Shares Outstanding | 13,084,243 | ||
Documents Incorporated by Reference | Portions of the definitive proxy statement for our 2023 annual meeting of stockholders, which is to be filed within 120 days after the end of the fiscal year ended December 31, 2022, are incorporated by reference into Part III of this Form 10-K, to the extent described in Part III. | ||
Entity Central Index Key | 0000827871 | ||
Document Fiscal Year Focus | 2022 | ||
Document Fiscal Period Focus | FY | ||
Amendment Flag | false |
Audit Information
Audit Information | 12 Months Ended |
Dec. 31, 2022 | |
Audit Information [Abstract] | |
Auditor Firm ID | 42 |
Auditor Name | Ernst & Young LLP |
Auditor Location | Stamford, Connecticut |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 55,321 | $ 97,659 |
Accounts receivable, net | 72,439 | 41,149 |
Inventories | 47,794 | 21,908 |
Prepaid expenses and other current assets | 13,200 | 11,890 |
Total current assets | 188,754 | 172,606 |
Property and equipment, net | 1,168 | 1,636 |
Intangible assets, net | 118,327 | 10,671 |
Goodwill | 45,033 | 39,743 |
Deferred tax asset | 27,146 | 18,798 |
Other assets | 25,732 | 10,278 |
Total assets | 406,160 | 253,732 |
Current liabilities: | ||
Accounts payable | 18,993 | 16,431 |
Accrued expenses and other liabilities | 85,844 | 32,338 |
Short-term debt | 6,250 | 25,607 |
Total current liabilities | 111,087 | 74,376 |
Other long-term liabilities | 5,297 | 2,903 |
Long-term debt | 56,216 | 0 |
Total liabilities | 172,600 | 77,279 |
Commitments and contingencies | ||
Stockholders' equity: | ||
Preferred stock, 1,500,000 shares authorized and no shares issued or outstanding as of December 31, 2022 and 2021 | 0 | 0 |
Common stock, $0.001 par value; 50,000,000 shares authorized; 17,569,375 and 16,903,034 shares issued as of December 31, 2022 and 2021, respectively | 18 | 17 |
Additional paid in capital | 366,265 | 325,779 |
Accumulated other comprehensive loss | (1,112) | (94) |
Retained earnings | 111,504 | 75,862 |
Treasury stock, at cost, 4,552,730 and 4,111,622 shares as of December 31, 2022 and 2021, respectively | (243,115) | (225,111) |
Total stockholders' equity | 233,560 | 176,453 |
Total liabilities and stockholders' equity | $ 406,160 | $ 253,732 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2022 | Dec. 31, 2021 |
Statement of Financial Position [Abstract] | ||
Preferred stock, shares authorized (in shares) | 1,500,000 | 1,500,000 |
Preferred stock, shares issued (in shares) | 0 | 0 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
Common stock, par value per share (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized (in shares) | 50,000,000 | 50,000,000 |
Common stock, shares, issued (in shares) | 17,569,375 | 16,903,034 |
Treasury stock (in shares) | 4,552,730 | 4,111,622 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Revenue: | |||
Total revenue | $ 316,610 | $ 171,546 | $ 187,802 |
Operating expenses: | |||
Cost of product sales | 85,458 | 31,528 | 33,647 |
Cost of royalty revenue | 9,478 | 10,652 | 11,818 |
Research and development | 34,088 | 51,275 | 30,785 |
Selling, general and administrative | 106,626 | 75,322 | 78,598 |
Total operating expenses | 235,650 | 168,777 | 154,848 |
Income from operations | 80,960 | 2,769 | 32,954 |
Interest income | 271 | 560 | 562 |
Interest expense | (4,045) | (1,635) | (2,577) |
Other expense | (15,753) | (6,242) | (8,262) |
Total other expense, net | (19,527) | (7,317) | (10,277) |
Income (loss) before income tax provision | 61,433 | (4,548) | 22,677 |
Income tax provision | (25,791) | (4,079) | (10,688) |
Net income (loss) | $ 35,642 | $ (8,627) | $ 11,989 |
Earnings (Loss) per common share: | |||
Basic (in dollars per share) | $ 2.76 | $ (0.66) | $ 0.89 |
Diluted (in dollars per share) | $ 2.73 | $ (0.66) | $ 0.87 |
Weighted average number of common shares outstanding: | |||
Basic (in shares) | 12,933,896 | 13,051,095 | 13,481,525 |
Diluted (in shares) | 13,065,494 | 13,051,095 | 13,771,393 |
Product sales, net | |||
Revenue: | |||
Total revenue | $ 214,536 | $ 65,023 | $ 72,323 |
Royalty revenue | |||
Revenue: | |||
Total revenue | 98,266 | 106,523 | 110,479 |
License and other revenue | |||
Revenue: | |||
Total revenue | $ 3,808 | $ 0 | $ 5,000 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive (Loss) Income - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Statement of Comprehensive Income [Abstract] | |||
Net income (loss) | $ 35,642 | $ (8,627) | $ 11,989 |
Other comprehensive income (loss), net of tax: | |||
Foreign currency translation | (1,112) | 0 | 0 |
Unrealized gain (loss) for convertible promissory note and other | 94 | (94) | 0 |
Total other comprehensive (loss) | (1,018) | (94) | 0 |
Comprehensive income (loss) | $ 34,624 | $ (8,721) | $ 11,989 |
Consolidated Statements of Chan
Consolidated Statements of Changes in Stockholders' Equity - USD ($) $ in Thousands | Total | Common Stock | Additional Paid-In Capital | Treasury Stock | Accumulated Other Comprehensive Loss | Retained Earnings |
Beginning balance (in shares) at Dec. 31, 2019 | 16,538,000 | |||||
Beginning balance at Dec. 31, 2019 | $ 179,174 | $ 17 | $ 278,518 | $ (171,861) | $ 0 | $ 72,500 |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Stock-based compensation expense | 24,756 | 24,756 | ||||
Issuance of common stock upon exercise of stock option grants (in shares) | 149,000 | |||||
Issuance of common stock upon exercise of stock option grants | 3,654 | 3,654 | ||||
Payment of employee withholding tax upon vesting of stock-based awards | (1,525) | (1,525) | ||||
Issuance of common stock related to vesting of restricted stock (in shares) | 52,000 | |||||
Issuance of common stock related to vesting of restricted stock | 0 | |||||
Common stock repurchases | (32,037) | (32,037) | ||||
Other comprehensive loss | 0 | |||||
Net income (loss) | 11,989 | 11,989 | ||||
Ending balance (in shares) at Dec. 31, 2020 | 16,739,000 | |||||
Ending balance at Dec. 31, 2020 | 186,011 | $ 17 | 305,403 | (203,898) | 0 | 84,489 |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Stock-based compensation expense | $ 19,555 | 19,555 | ||||
Issuance of common stock upon exercise of stock option grants (in shares) | 122,847 | 101,000 | ||||
Issuance of common stock upon exercise of stock option grants | $ 2,398 | 2,398 | ||||
Issuance of common stock related to vesting of restricted stock (in shares) | 63,000 | |||||
Issuance of common stock related to vesting of restricted stock | (1,577) | (1,577) | ||||
Common stock repurchases | (21,213) | (21,213) | ||||
Other comprehensive loss | (94) | (94) | ||||
Net income (loss) | (8,627) | (8,627) | ||||
Ending balance (in shares) at Dec. 31, 2021 | 16,903,000 | |||||
Ending balance at Dec. 31, 2021 | 176,453 | $ 17 | 325,779 | (225,111) | (94) | 75,862 |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Stock-based compensation expense | $ 16,451 | 16,451 | ||||
Issuance of common stock upon exercise of stock option grants (in shares) | 91,255 | 76,000 | ||||
Issuance of common stock upon exercise of stock option grants | $ 1,747 | 1,747 | ||||
Issuance of common stock related to business acquisition (in shares) | 516,000 | |||||
Issuance of common stock related to business acquisition | 23,645 | $ 1 | 23,644 | |||
Issuance of common stock related to vesting of restricted stock (in shares) | 74,000 | |||||
Issuance of common stock related to vesting of restricted stock | (1,356) | (1,356) | ||||
Common stock repurchases | (18,004) | (18,004) | ||||
Other comprehensive loss | (1,018) | (1,018) | ||||
Net income (loss) | 35,642 | 35,642 | ||||
Ending balance (in shares) at Dec. 31, 2022 | 17,569,000 | |||||
Ending balance at Dec. 31, 2022 | $ 233,560 | $ 18 | $ 366,265 | $ (243,115) | $ (1,112) | $ 111,504 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Cash flows from operating activities: | |||
Net income (loss) | $ 35,642 | $ (8,627) | $ 11,989 |
Adjustments to reconcile net income (loss) to net cash provided by operating activities: | |||
Deferred income taxes | (8,324) | (3,618) | (1,511) |
Depreciation expense | 646 | 764 | 872 |
Noncash operating lease expense related to right-of-use assets | 1,243 | 1,046 | 1,228 |
Amortization expense of intangible assets | 11,378 | 2,996 | 2,666 |
Convertible promissory note related credit losses | 0 | 758 | 0 |
Stock-based compensation expense | 16,451 | 19,555 | 24,756 |
Fair value adjustments on equity investment | 4,457 | 6,170 | 5,300 |
Amortization of debt issuance costs | 469 | 472 | 419 |
Fair value adjustments on settled accelerated share repurchase agreement | 0 | 0 | 2,962 |
Fair value adjustments related to derivative instrument | 962 | (686) | 0 |
Gain on fair value adjustments related to debt | (263) | 0 | 0 |
Accretion of discount on convertible promissory note | 0 | (148) | 0 |
Loss on write-off of promissory note | 4,444 | 0 | 0 |
Changes in operating assets and liabilities which provided (used) cash: | |||
Accounts receivable | (30,832) | 9,529 | (3,113) |
Inventories | (8,339) | (13,833) | (1,509) |
Prepaid expenses and other current assets | (5,155) | (2,770) | 11,386 |
Accounts payable | 2,966 | 10,162 | 806 |
Accrued expenses and other liabilities | 43,580 | 7,770 | (4,429) |
Other assets and other long-term liabilities, net | (18,624) | (1,321) | (2,325) |
Net cash provided by operating activities | 50,701 | 28,219 | 49,497 |
Cash flows from investing activities: | |||
Purchase of Acacia, net of cash acquired | (74,152) | 0 | 0 |
Purchase of equity investment security | (12,500) | 0 | (17,500) |
Purchase of property and equipment | (178) | (323) | (747) |
Purchase of convertible promissory note | 0 | (5,000) | 0 |
Net cash used in investing activities | (86,830) | (5,323) | (18,247) |
Cash flows from financing activities: | |||
Repurchases of common stock | (18,004) | (21,213) | (34,999) |
Proceeds from existing revolving credit facility | 30,000 | 0 | 110,000 |
Repayment of existing revolving credit facility | (15,000) | 0 | (110,000) |
Debt proceeds | 50,000 | 0 | 0 |
Payment of debt | (52,236) | (8,000) | (5,000) |
Payment of debt financing costs | (1,360) | 0 | 0 |
Payment of employee withholding tax upon vesting of stock-based awards | (1,356) | (1,577) | (1,525) |
Payments for employee net option exercises | 0 | 0 | 0 |
Proceeds from common stock option exercises | 1,747 | 2,398 | 3,654 |
Net cash used in financing activities | (6,209) | (28,392) | (37,870) |
Net decrease in cash and cash equivalents | (42,338) | (5,496) | (6,620) |
Cash and cash equivalents at beginning of period | 97,659 | 103,155 | 109,775 |
Cash and cash equivalents at end of period | 55,321 | 97,659 | 103,155 |
Cash paid during the period for: | |||
Income taxes, net | 28,410 | 10,005 | 6,428 |
Interest | 1,726 | 1,197 | 2,224 |
Right-of-use asset obtained in exchange for lease obligation, inclusive of a lease amendment | $ 0 | $ 270 | $ 855 |
Organization and Business
Organization and Business | 12 Months Ended |
Dec. 31, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization and Business | Organization and Business Eagle Pharmaceuticals, Inc. (the "Company", "Eagle", or "we") is an integrated pharmaceutical company focused on finding ways to help medicines do more for patients. We and our collaborators have the capabilities to take a molecule from preclinical research through regulatory approval and into the marketplace, including development, manufacturing and commercialization. Our business model applies our scientific expertise, proprietary research-based insights and marketplace proficiency to identify challenging-to-treat diseases of the central nervous system or metabolic critical care therapeutic areas as well as in oncology. By focusing on patients' unmet needs, we strive to provide healthcare professionals with urgently needed treatment solutions that are designed to improve patient care and outcomes and create near- and long-term value for our stakeholders, including patients and healthcare providers and our employees, marketing partners, collaborators and investors. Our science-based business model has a proven track record with the U.S. Food and Drug Administration ("FDA") approval and commercial launches of six products: PEMFEXY® (pemetrexed for injection), vasopressin, an A-rated generic alternative to Vasostrict®, Ryanodex® (dantrolene sodium) ("Ryanodex"), bendamustine ready-to-dilute ("RTD") 500ml solution ("Belrapzo"), and rapidly infused bendamustine RTD ("Bendeka") and bendamustine ready-to-dilute and rapidly infused RTD in Japan (“Treakisym”). We market our products through marketing partners and/or our internal direct sales force. We market PEMFEXY, vasopressin, Ryanodex and Belrapzo, and Teva Pharmaceutical Industries Ltd. ("Teva") markets Bendeka through its subsidiary Cephalon, Inc. SymBio Pharmaceuticals Limited ("SymBio"), markets Treakisym, a RTD product, in Japan. On June 9, 2022, we acquired all of the outstanding share capital of Acacia Pharma Group plc ("Acacia"), which added two FDA approved new chemical entities with patent protection, BARHEMSYS® (amisulpride for injection) and BYFAVO® (remimazolam for injection). Refer to Note 15 for further details. Segment Information |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Summary of Significant Accounting Policies Business combinations and Asset Acquisitions The Company evaluates acquisitions of assets and other similar transactions to assess whether or not the transaction should be accounted for as a business combination or asset acquisition by first applying a screen test to determine if substantially all of the fair value of the gross assets acquired is concentrated in a single identifiable asset or group of similar identifiable assets. If the screen test is met, the transaction is accounted for as an asset acquisition. If the screen test is not met, further determination is required as to whether or not the Company has acquired inputs and processes that have the ability to create outputs, which would meet the requirements of a business. If determined to be a business combination, the Company accounts for the transaction under the acquisition method of accounting as indicated in ASU 2017-01, Business Combinations (Topic 805): Clarifying the Definition of a Business, which requires the acquiring entity in a business combination to recognize the fair value of all assets acquired, liabilities assumed, and any non-controlling interest in the acquiree and establishes the acquisition date as the fair value measurement point. Accordingly, the Company recognizes assets acquired and liabilities assumed in business combinations, including contingent assets and liabilities, and non-controlling interest in the acquiree based on the fair value estimates as of the date of acquisition. In accordance with ASC 805, Business Combinations, the Company recognizes and measures goodwill as of the acquisition date, as the excess of the fair value of the consideration paid over the fair value of the identified net assets acquired. If determined to be an asset acquisition, the Company accounts for the transaction under ASC 805-50, which requires the acquiring entity in an asset acquisition to recognize assets acquired and liabilities assumed based on the cost to the acquiring entity on a relative fair value basis, which includes transaction costs in addition to consideration given. No gain or loss is recognized as of the date of acquisition unless the fair value of non-cash assets given as consideration differs from the assets’ carrying amounts on the acquiring entity’s books. Consideration transferred that is non-cash will be measured based on either the cost (which shall be measured based on the fair value of the consideration given) or the fair value of the assets acquired and liabilities assumed, whichever is more reliably measurable. Goodwill is not recognized in an asset acquisition and any excess consideration transferred over the fair value of the net assets acquired is allocated to the identifiable assets based on relative fair values. Use of Estimates These financial statements are presented in U.S. dollars and are prepared in accordance with U.S. GAAP. The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements including disclosure of contingent assets and contingent liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period and accompanying notes. Our critical accounting policies are those that are both most important to our financial condition and results of operations and require the most difficult, subjective or complex judgments on the part of management in their application, often as a result of the need to make estimates about the effect of matters that are inherently uncertain. As of the date of issuance of these financial statements, we are not aware of any specific event or circumstance that would require us to update our estimates, assumptions and judgments or revise the carrying value of our assets or liabilities. Because of the uncertainty of factors surrounding the estimates or judgments used in the preparation of the financial statements, actual results may materially vary from these estimates, and any such differences may be material to our financial statements. Revenue from sales of products is recognized at the point where the customer obtains control of the goods and we satisfy our performance obligation, which generally is at the time we ship the product to the customer. Provisions for chargebacks, rebates, discounts, and returns are established in the same period the related sales are recognized. Significant judgments must be made in determining the transaction price for our sales of products related to anticipated rebates, discounts and returns. Refer below for further details. Reclassifications Certain reclassifications have been made to prior year amounts to conform with the current year presentation in certain notes to these consolidated financial statements. Cash and Cash Equivalents The Company considers cash and cash equivalents to be highly liquid investments with an original maturity of three months or less from the date of purchase. All cash and cash equivalents are held in United States financial institutions. The carrying amount of cash and cash equivalents a pproximates its fair value due to its short-term nature. We, at times, maintain balances with financial institutions in excess of the Federal Deposit Insurance Corporation limit. Fair Value Measurements U.S. GAAP establishes a framework for measuring fair value under generally accepted accounting principles and enhances disclosures about fair value measurements. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. The standard describes the following fair value hierarchy based on three levels of inputs, of which the first two are considered observable and the last unobservable, that may be used to measure fair value: • Level 1: Quoted prices in active markets for identical assets or liabilities. • Level 2: Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. • Level 3: Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. The fair value of interest-bearing cash, cash equivalents, accounts receivable and accounts payable approximate fair value due to their life being short term in nature, and are classified as Level 1 for all periods presented. The following tables present the Company’s hierarchy for its assets measured at fair value as of December 31, 2022 and 2021: December 31, 2022 Total Level 1 Level 2 Level 3 Assets: Money market funds $ 47,567 $ 47,567 $ — $ — Investment in Syros Pharmaceuticals, Inc. ("Syros") 1,573 1,573 — — Investment in Enalare Therapeutics, Inc. 8,438 — — 8,438 Acquisition rights of Enalare Therapeutics, Inc. 8,125 — — 8,125 Liability: Forward Liability 4,063 — — 4,063 December 31, 2021 Total Level 1 Level 2 Level 3 Assets: Money market funds $ 57,357 $ 57,357 $ — $ — Convertible promissory note 4,021 — — 4,021 Embedded derivative asset in convertible promissory note 962 — — 962 Investment in Syros 6,030 6,030 The Company recognizes transfers between levels within the fair value hierarchy, if any, at the end of each quarter. There were no transfers in or out of Level 1, Level 2 or Level 3 during the years ended December 31, 2022 and 2021, respectively. Our investment in Enalare Therapeutics Inc., ("Enalare"), acquisition right and forward liability were classified as Level 3. We analyzed and assessed the contractual obligation to invest another $12.5 million within six months from August 2022, along with the purchase option included within the Securities Purchase Agreement (“SPA”). We used a probability factor to value the asset related to the acquired acquisition rights based on management's best estimate, including the probability of completion of certain development milestones. The equity stake was accounted for as non-readily determinable fair value ("non-RDFV”) investment. The equity investment, acquisition right and forward liability was reported at fair value as of December 31, 2022. Refer to N ote 11, Investment in Enalare Therapeutics Inc. for further information. Our investment in restricted shares of common stock of Syros Pharmaceuticals, Inc. ("Syros"), following the merger of Tyme Technologies, Inc. (“Tyme”) and Syros on September 16, 2022, are classified as Level 1. Refer to Note 9, License and Collaboration Agreements for further details. As of December 31, 2021, our investment in the convertible promissory note and the embedded derivative were classified as Level 3. We analyzed and assessed the embedded derivative feature contained in the convertible promissory note agreement. We used a probability factor to value the embedded derivative asset based on management's best estimate, including the principal and estimated accrued interest among other contractual terms. The convertible promissory note was accounted for as available for sale. The convertible promissory note was reported at fair value with unrealized gains and losses included in Accumulated other comprehensive income (loss). Refer to Note 14, Convertible Promissory Note for further details. Refer to Note 15. Business Acquisition for details regarding fair value measurements in connection with our acquisition of Acacia. The fair value of debt is classified as Level 2 for the periods presented and approximates its fair value due to the variable interest rate. Intangible Assets Finite-lived intangible assets are measured at their respective fair values on the date they were recorded at the date of subsequent adjustments of fair value and stated net of accumulated amortization. The fair values assigned to the Company's intangible assets are based on reasonable estimates and assumptions given available facts and circumstances. The Company amortizes its definite-lived intangible assets using either the straight-line or accelerated method, based on the useful life of the asset over which it is expected to be consumed utilizing expected undiscounted future cash flows. The Company reviews the recoverability of its finite-lived intangible assets and long-lived assets for indicators of impairments. Events or circumstances that may require an impairment assessment significant changes in our forecasted projections for the asset or asset group for reasons including, but not limited to, significant under-performance of a product in relation to expectations, significant changes or planned changes in our use of the assets, significant negative industry or economic trends, and new or competing products that enter the marketplace. If such indicators are present, the Company assesses the recoverability of affected assets by determining if the carrying value of such assets is less than the sum of the undiscounted future cash flows of the assets. If such assets are found to not be recoverable, the Company measures the amount of the impairment by comparing the carrying value of the assets to the fair value of the assets. The Company determined that no indicators of impairment of finite-lived intangible assets or long-lived assets existed as of December 31, 2022. Goodwill Goodwill represents the excess of purchase price over the fair value of net assets acquired in the Eagle Biologics and Acacia acquisition. Goodwill is not amortized, but is evaluated for impairment on an annual basis, in the fourth quarter, or more frequently if events or changes in circumstances indicate that the fair value of the reporting unit’s goodwill is less tha n it's carrying amount. The Company performed a qualitative annual test for goodwill as of October 1, 2022. During the year ended December 31, 2022, the Company concluded that no impairment exists. Concentration of Major Customers and Vendors The Company is exposed to risks associated with extending credit to customers related to the sale of products. The Company does not require collateral to secure amounts due from its customers. The Company uses an expected loss methodology to calculate allowances for trade receivables. The Company's measurement of expected credit losses is based on relevant information about past events, including historical experience, current conditions, and reasonable and supportable forecasts that affect the collectability of the reported amount. The Company does not currently have a material allowance for collectible trade receivables. Further, the Company is dependent on its commercial partner to market and sell Bendeka; therefore, the Company's future revenues are highly dependent on the collaboration and distribution arrangement with Teva. Teva markets Bendeka through a license agreement with the Company. Pursuant to that license agreement, Teva pays the Company a royalty based on net sales of the product and also purchases the product from the Company. A disruption in this arrangement, caused by, among other things, a supply disruption, loss of exclusivity or the launch of a superior product would have a material adverse effect of the Company’s financial position, results of operations and cash flows. The total revenues and accounts receivables broken down by major customers as a percentage of the total are as follows: Year Ended December 31, 2022 2021 2020 Total revenues Teva - See Revenue Recognition 33 % 66 % 67 % Customer A 19 % 7 % 10 % Customer B 12 % 9 % 5 % Customer C 12 % 4 % 2 % Customer D 9 % 8 % 9 % Other 15 % 6 % 7 % 100 % 100 % 100 % December 31, 2022 2021 Accounts receivable Teva - See Revenue Recognition 31 % 63 % Customer A 1 % 13 % Customer B 57 % 13 % Customer C 5 % 2 % Customer D 2 % 2 % Other 4 % 7 % 100 % 100 % Inventories Inventories are recorded at the lower of cost and net realizable value, with cost determined on a first-in first-out basis. The Company periodically reviews the composition of its inventories in order to identify obsolete, slow-moving or otherwise non-saleable items. If non-saleable items are observed and there are no alternate uses for the inventories, the Company will record a write-down to net realizable value in the period that the decline in value is first recognized. Property and Equipment Property and equipment are stated at cost. Depreciation is recorded over the estimated useful lives of the assets utilizing the straight-line method. Leasehold improvements are being amortized over the shorter of their useful lives or the lease term. Research and Development Expense Costs for research and development are charged to expense as incurred and include; employee-related expenses including salaries, benefits, travel and stock-based compensation expense for research and development personnel; expenses incurred under agreements with contract research organizations, contract manufacturing organizations and service providers that assist in conducting clinical and preclinical studies; costs associated with preclinical activities and development activities, costs associated with regulatory operations; and depreciation expense for assets used in research and development activities. Costs for certain development activities, such as in licensing intellectual property related to new projects, clinical studies, are recognized based on an evaluation of the progress to completion of specific tasks using data such as patient enrollment, clinical site activations, or information provided to us by our vendors on their actual costs incurred. Payments for these activities are based on the terms of the individual arrangements, which may differ from the patterns of costs incurred, and are reflected in the consolidated financial statements as prepaid expenses or accrued expenses as deemed appropriate. Recoveries of previously recognized research and development expenses from third parties are recorded as a reduction to research and development expense in the period it becomes realizable. Advertising and Marketing Advertising and marketing costs are expensed as incurred. Advertising and marketing costs were $8.5 million, $2.6 million, and $2.7 million for the year ended December 31, 2022, 2021, and 2020, respectively. Income Taxes We account for income taxes using the liability method in accordance with Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”), Topic 740 - Income Taxes (“ASC 740”). Deferred tax assets and liabilities are determined based on temporary differences between financial reporting and tax bases of assets and liabilities and are measured by applying enacted rates and laws to taxable years in which differences are expected to be recovered or settled. Further, the effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that the rate changes. A valuation allowance is required when it is “more likely than not” that all or a portion of deferred tax assets will not be realized. ASC 740 also prescribes a comprehensive model for how a company should recognize, measure, present and disclose in its financial statements uncertain tax positions that the company has taken or expects to take on a tax return, including a decision whether to file or not file a return in a particular jurisdiction. We recognize any interest and penalties accrued related to unrecognized tax benefits as income tax expense. Revenue Recognition Revenue is recognized when a customer obtains control of promised goods or services, in an amount that reflects the consideration which the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of ASC 606, the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. The Company only applies the five-step model to contracts when it is probable that the entity will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of ASC 606, the Company assesses the goods or services promised within each contract and determines those that are performance obligations, and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. Sales, value add, and other taxes collected on behalf of third parties are excluded from revenue. Product revenue - The Company recognizes net revenue on sales to its commercial partners and to end users. In each instance, revenue is generally recognized when the customer obtains control of the Company’s product, which occurs at a point in time, and may be upon shipment or upon delivery based on the contractual shipping terms of a contract. Receivables from our product sales have payment terms ranging from 30 to 75 days with select extended terms to wholesalers on initial purchases of product launch quantities. Revenue is measured as the amount of consideration the Company expects to receive in exchange for transferring products or services to a customer. To the extent the transaction price includes variable consideration, the Company estimates the amount of variable consideration that should be included in the transaction price generally utilizing the expected value method to which the Company expects to be entitled. As such, revenue on sales to end users for vasopressin, PEMFEXY, Belrapzo, Ryanodex, BARHEMSYS, and BYFAVO are recorded net of chargebacks, rebates, returns, prompt pay discounts, wholesaler fees and other deductions. Our products are contracted with a limited number of oncology distributors and hospital buying groups with narrow differences in ultimate realized contract prices used to estimate our allowance for chargebacks and rebate reserves. The Company has a product returns policy on some of its products that allows the customer to return pharmaceutical products within a specified period of time both prior to and subsequent to the product’s expiration date. The Company's estimate of the provision for returns is analyzed quarterly and is based upon many factors, including historical experience of actual returns and analysis of the level of inventory in the distribution channel, if any. The Company has terms on sales of Ryanodex by which the Company does not accept returns. Variable consideration is included in the transaction price if, in the Company’s judgment, it is probable that a significant future reversal of cumulative revenue under the contract will not occur. Estimates of variable consideration are made generally using the expected value method and determination of whether to include estimated amounts in the transaction price are based largely on an assessment of the Company’s anticipated performance and all information (historical, current and forecasted) that is reasonably available. The Company believes that the estimates it has established are reasonable based upon current facts and circumstances. Applying different judgments to the same facts and circumstances could result in the estimated amounts to vary. Components of Gross-to-Net (GTN) Estimates Chargebacks : Chargebacks are discounts that occur when certain contracted customers, including group purchasing organizations (“GPOs”), public health service institutions and federal government entities purchasing via the Federal Supply Schedule, purchase from the Company's distributors. The Company's distributors purchase product from us at invoice price, then resell the product to certain contracted customers on the basis of prices negotiated between us and the providers. The difference between the distributors’ purchase price and the typically lower certain contracted customers’ purchase price is refunded to the distributors through a chargeback credit. We record estimates for these chargebacks at the time of sale as deductions from gross revenues, with corresponding adjustments to our accounts receivable reserves and allowances. The provision for chargebacks is the most significant provision in the context of the Company’s gross-to-net adjustments in the determination of net revenue. Chargebacks are estimated based on payer mix and contracted price, adjusted for current period assumptions. Commercial and Medicaid Rebates : The Company contracts with government agencies or collectively, third-party payors, so that vasopressin, PEMFEXY, Belrapzo, Ryanodex, BARHEMSYS, and BYFAVO will be eligible for purchase by, or partial or full reimbursement from, such third-party payors. The Company estimates the rebates it will provide to third-party payors and deducts these estimated amounts from total gross product revenues at the time the revenues are recognized. These reserves are recorded in the same period in which the revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability. The current liability is included in accrued expenses and other current liabilities on the consolidated balance sheets. The Company estimates the rebates that it will provide to third-party payors based upon (i) the Company’s contracts with these third-party payors, (ii) the government mandated discounts applicable to government-funded programs, (iii) a range of possible outcomes that are probability-weighted for the estimated payer mix, and (iv) information obtained from the Company’s distributors. The information that the Company also considers when establishing its rebate reserves are purchases by customers, projected annual sales for customers, actual rebates payments made, processing time lags, and for indirect rebates, the level of inventory in the distribution channel that will be subject to indirect rebates. We do not provide incentives designed to increase shipments to our customers that we believe would result in out-of-the-ordinary course of business inventory for them. The Company regularly reviews and monitors estimated or actual customer inventory information at its largest distributors for its key products to ascertain whether customer inventories are in excess of ordinary course of business levels. Product Returns : The Company's provision for product returns based on the factors noted above generally encompass a time range from 12 to 48 months after revenue is recognized. The Company’s distributors have the right to return unopened unprescribed vasopressin, PEMFEXY, Belrapzo, BARHEMSYS, and BYFAVO during certain time periods around the period beginning prior to the labeled expiration date and ending after the labeled expiration date. The Company estimates future product returns on sales of vasopressin, PEMFEXY, Belrapzo, BARHEMSYS, and BYFAVO based on: (i) data provided to the Company by its distributors (including weekly reporting of distributors’ sales and inventory held by distributors that provided the Company with visibility into the distribution channel in order to determine what quantities were sold to retail pharmacies and other providers), (ii) data provided to the Company by a third-party data provider which collects and publishes prescription data, and other third parties, (iii) historical industry information regarding return rates for similar pharmaceutical products, (iv) the estimated remaining shelf life of vasopressin, PEMFEXY, Belrapzo, BARHEMSYS, and BYFAVO previously shipped and currently being shipped to distributors and (v) contractual agreements intended to limit the amount of inventory maintained by the Company’s distributors. These reserves are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability which is included in accrued expenses and other current liabilities on the consolidated balance sheets. Wholesaler fees and other incentives : The Company generally provides invoice discounts on vasopressin, PEMFEXY, Belrapzo, Ryanodex, BARHEMSYS, and BYFAVO sales to its distributors for prompt payment and fees for distribution services, such as fees for certain data that distributors provide to the Company. The payment terms for sales to distributors generally include a 2% discount for prompt payment which is generally defined in invoice terms as a range from 15 to 45 days, while the fees for distribution services are based on contractual rates agreed with the respective distributors. Based on historical data, the Company expects its distributors to earn these discounts and fees, and deducts the full amount of these discounts and fees from its gross product revenues and accounts receivable at the time such revenues are recognized. In certain cases, the Company may record the fees as accrued expenses if the Company expects that the fees will be paid rather than deducted by the distributor. The Company recorded product sales, net as follows: Year Ended December 31, 2022 2021 2020 (in thousands) PEMFEXY $ 67,479 $ — $ — Vasopressin 63,159 — — Bendeka 12,992 11,167 15,439 Belrapzo 33,667 23,728 27,527 Ryanodex 30,164 25,271 28,268 Other 7,075 4,857 1,089 Product sales, net $ 214,536 $ 65,023 $ 72,323 The following table provides a summary roll-forward of the Company's net product revenue allowances and related reserves for the years ended December 31, 2022 and 2021, on the consolidated balance sheets (in thousands): Chargebacks Commercial Rebates Medicaid Rebates Product Returns Wholesaler Fees and Other Incentives Total Balance at December 31, 2020 $ 2,289 $ 1,772 $ 684 $ 1,666 $ 5,391 $ 11,802 Provisions / Adjustments 27,402 3,042 268 2,531 9,650 42,893 Charges processed / Payments (25,852) (2,838) (332) (2,674) (13,070) (44,766) Balance at December 31, 2021 $ 3,839 $ 1,976 $ 620 $ 1,523 $ 1,971 $ 9,929 Provisions / Adjustments 118,575 28,109 1,722 4,893 34,505 187,804 Charges processed / Payments (98,807) (9,399) (368) (365) (21,892) (130,831) Balance at December 31, 2022 $ 23,607 $ 20,686 $ 1,974 $ 6,051 $ 14,584 $ 66,902 Such net product revenue allowances and reserves are included within accounts receivable, net and accrued expenses and other current liabilities within the consolidated balance sheets. Royalty Revenue — The Company recognizes revenue from license arrangements with its commercial partners' net sales of products. Royalties are recognized as earned in accordance with contract terms when they can be reasonably estimated and collectability is reasonably assured. The Company's commercial partners are obligated to report their net product sales and the resulting royalty due to the Company within 25 days from the end of each quarter. Based on historical product sales, royalty receipts and other relevant information, the Company accrues royalty revenue each quarter and subsequently determines a true-up when it receives royalty reports from its commercial partners. Historically, these true-up adjustments have been immaterial. Our receivables from royalty revenue are due 45-days from the end of the quarter.. License and other revenue — The Company analyzes each element of its licensing agreements to determine the appropriate revenue recognition. The terms of the license agreement may include payment to us of non-refundable up-front license fees, milestone payments if specified objectives are achieved, and/or royalties on product sales. The Company recognizes revenue from upfront payments at a point in time, typically upon fulfilling the delivery of the associated intellectual property to the customer. If the contract contains a single performance obligation, the entire transaction price is allocated to the single performance obligation. Contracts that contain multiple performance obligations require an allocation of the transaction price based on the estimated relative standalone selling prices of the promised products or services underlying each performance obligation. The Company determines standalone selling prices based on the price at which the performance obligation is sold separately. If the standalone selling price is not observable through past transactions, the Company estimates the standalone selling price taking into account available information such as market conditions and internally approved pricing guidelines related to the performance obligations. The Company recognizes sales-based milestone payments as revenue upon the achievement of the cumulative sales amount specified in the contract in accordance with ASC 606-10-55-65. For those milestone payments which are contingent on the occurrence of particular future events, the Company determined that these need to be considered for inclusion in the calculation of total consideration from the contract as a component of variable consideration using the most-likely amount method. As such, the Company assesses each milestone to determine the probability and substance behind achieving each milestone. Given the inherent uncertainty of the occurrence of these future events, the Company will not recognize revenue from the milestone until there is not a high probability of a reversal of revenue, which typically occurs near or upon achievement of the event. When determining the transaction price of a contract, an adjustment is made if payment from a customer occurs either significantly before or significantly after performance, resulting in a significant financing component. Applying the practical expedient in paragraph 606-10-32-18, the Company does not assess whether a significant financing component exists if the period between when the Company performs its obligations under the contract and when the customer pays is one year or less. None of the Company’s contracts contained a significant financing component as of December 31, 2022. Stock-Based Compensation The Company utilizes stock-based compensation in the form of stock optio |
Inventories
Inventories | 12 Months Ended |
Dec. 31, 2022 | |
Inventory Disclosure [Abstract] | |
Inventories | Inventories The Company's inventory balance consists of the following: December 31, 2022 2021 Raw materials $ 12,348 $ 7,317 Work-in-process 14,064 9,666 Finished goods 21,382 4,925 $ 47,794 $ 21,908 |
Property and Equipment, net
Property and Equipment, net | 12 Months Ended |
Dec. 31, 2022 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment, net | Property and Equipment, net Property and equipment consists of the following: December 31, Estimated Useful Life (years) 2022 2021 Furniture and fixtures $ 1,525 $ 1,525 7 Office equipment 1,077 1,077 3 Equipment 4,012 3,834 7 Leasehold improvements 1,155 1,155 2 7,769 7,591 Less accumulated depreciation (6,601) (5,955) Property and equipment, net $ 1,168 $ 1,636 |
Balance Sheet Accounts
Balance Sheet Accounts | 12 Months Ended |
Dec. 31, 2022 | |
Balance Sheet Related Disclosures [Abstract] | |
Balance Sheet Accounts | Balance Sheet Accounts Prepaid expenses and Other Current Assets Prepaid and other current assets consist of the following: December 31, 2022 2021 Advances to commercial manufacturers $ 5,464 $ 2,354 Prepaid FDA user fee and advances to CROs 3,022 1,108 Prepaid insurance 258 196 Prepaid income taxes 90 1,173 Prepaid R&D 106 — Convertible promissory note, net — 5,312 Pass-through receivables 1,001 347 All other 3,259 1,400 Total Prepaid expenses and other current assets $ 13,200 $ 11,890 Accrued Expenses and Other Liabilities Accrued expenses and other liabilities consist of the following: December 31, 2022 2021 Royalties payable to commercial partners $ 7,205 $ 5,085 Accrued research & development 1,549 4,100 Accrued professional fees 5,541 2,013 Accrued salary and other compensation 5,293 8,466 Accrued product sales reserves 33,000 4,390 Current portion of lease liability 1,534 1,309 Inventory received but not invoiced 6,779 6,177 Income taxes payable 5,182 — Forward liability related to Enalare 4,063 — PEMFEXY royalty buy-down payable 15,000 — All other 698 798 Total Accrued expenses and other liabilities $ 85,844 $ 32,338 Leases We lease office space in Woodcliff Lake, New Jersey for our principal office under an amended lease agreement through June 2025. We also lease a lab space in Cambridge, Massachusetts under a lease agreement through April 2024, office space located in Indianapolis, Indiana through November 2023, and an office space located in Palm Beach Gardens, Florida. All of our leases are classified as operating leases and have remaining lease terms of approximately 2.0 years. The principal office and the lab space leases include renewal options to extend the lease for up to 5 years. Furthermore, we have not elected the practical expedient to separate lease and non-lease components for all classes of underlying assets. The table below summarizes the Company's total lease costs included in the consolidated financial statements, as well as other required quantitative disclosures (in thousands): As of December 31, 2022 2021 Operating lease cost $ 1,507 $ 1,407 Total lease cost $ 1,507 $ 1,407 Other information: Cash paid for amounts included in the measurement of lease liabilities Operating cash flows for operating leases $ 1,507 $ 1,407 Right-of-use assets obtained in exchange for new operating lease liabilities $ — $ 270 Weighted-average remaining lease term - operating leases 2.1 years 3.1 years Weighted-average discount rate - operating leases 6.0 % 6.0 % Balance Sheet Classification as of December 31, 2022 Current lease liabilities (included with Accrued expenses and other liabilities) $ 1,534 Long-term lease liabilities (included with Other long-term liabilities) 1,508 Total lease liabilities $ 3,042 |
Debt
Debt | 12 Months Ended |
Dec. 31, 2022 | |
Debt Disclosure [Abstract] | |
Debt | Debt On November 1, 2022, we entered into the Third Amended and Restated Credit Agreement, which replaced the Second Amended Credit Agreement. The terms and amounts borrowed under the Third Amended Credit Agreement includes a drawn term loan of $50 million and a $100 million revolving credit facility of which $15 million was drawn on November 1, 2022. On the effective date for the Third Amended Credit Agreement, we borrowed $15 million under the revolving credit facility and $50 million under the term loan facility. Approximately $35.4 million of the proceeds of the credit facility were used to refinance all amounts outstanding under the Second Amended Credit Agreement, to repay €25 million indebtedness of Acacia, and for other corporate purposes. All amounts outstanding under the Third Amended Credit Agreement shall be due and payable on October 31, 2025, unless otherwise accelerated or extended pursuant to the terms of the Third Amended Credit Agreement. The Third Amended Credit Agreement contains customary representations and warranties and customary affirmative and negative covenants applicable to us and our consolidated subsidiaries, including, among other things, restrictions on indebtedness, liens, investments, mergers, dispositions, prepayment of other indebtedness and dividends and other distributions. Under the terms of the Third Amended Credit Agreement, we are required to comply with (a) a maximum total net leverage ratio, (b) a fixed charge coverage ratio and (c) a minimum liquidity covenant. As of December 31, 2022, we were in compliance with total net leverage ratio; fixed charge coverage ratio; and liquidity covenants. Loans under the Third Amended Credit Agreement bear interest, at our option, at a rate equal to either (a) the SOFR rate, plus a credit adjustment spread, plus an applicable margin ranging from 2.50% to 3.25% per annum, based upon the total net leverage ratio (as defined in the Third Amended Credit Agreement), or (b) the prime lending rate, plus an applicable margin ranging from 1.50% to 2.25% per annum, based upon the total net leverage ratio. We are required to pay a commitment fee on the unused portion of the new revolving credit facility in the Third Amended Credit Agreement at a rate ranging from 0.38% to 0.48% per annum based upon the total net leverage ratio. The term loan facility payments will be made in quarterly installments in an amount equal to $1.25 million per fiscal quarter for each fiscal quarter ended after the closing date for the Third Amended Credit Agreement through the fiscal quarter ended September 30, 2023, and in an amount equal to $2.5 million per fiscal quarter for each fiscal quarter thereafter. As of December 31, 2022, we classified debt related to term loan of $6.25 million as current on our consolidated balance sheet. As of June 9, 2022, upon closing of our acquisition of Acacia Pharma Group plc ("Acacia"), we guaranteed a term loan facility, dated as of January 10, 2020, by and between Acacia Pharma Limited (“APL”), a direct subsidiary of Acacia, and Cosmo Technologies Ltd. (the “Term Loan Facility”). The Term Loan Facility provides for up to €25 million in loans, all of which were drawn as of closing of the acquisition. The term loan facility bears an annual interest rate of 9% with periodic payments through September 30, 2025. See Note 15 Business Acquisition for further information on our acquisition of Acacia Pharma. The guarantee provided that we shall guarantee the punctual performance by APL of APL’s obligations pursuant to the terms of the Term Loan Facility (as amended) and that we will immediately on demand pay any amount owed by APL under the Term Loan Facility (as amended) as if we were the principal obligor in the event that such amount is not paid by APL. On November 8, 2019, we entered into the Second Amended and Restated Credit Agreement (the “Prior Credit Agreement”), with JPMorgan Chase Bank, N.A., as administrative agent (the “Administrative Agent”) and the lenders party thereto. The terms and amounts borrowed under the Prior Credit Agreement includes a drawn term loan of $40 million and a revolving credit facility of $110 million. During the third quarter of 2022, we drew down $15 million from our revolving credit facility under the Second Amended Credit Agreement. The term loan facility under the Second Credit Agreement bore interest at the Adjusted LIBOR (equal to (a) the LIBOR for such Interest Period multiplied by (b) the Statutory Reserve Rate as established by Board of Governors of the Federal Reserve System of the United States of America) for the interest period in effect for such borrowing plus the applicable rate as described below. Loans under the Second Credit Agreement bore interest at a rate equal to either (a) the LIBOR rate, plus an applicable margin ranging from 2.25% to 3.0% per annum, based upon the total net leverage ratio (as defined in the Prior Credit Agreement), or (b) the Benchmark Replacement which is defined as the greatest of the prime lending rate, or the NYFRB Rate (the rate for a federal funds transaction) in effect on such day plus ½ of 1% or the Adjusted LIBO Rate for a one month Interest Period on such day plus 1% plus an applicable margin ranging from 1.25% to 2.0% per annum, based upon the total net leverage ratio. We were required to pay a commitment fee on the unused portion of the new revolving credit facility in the Prior Credit Agreement at a rate ranging from 0.35% to 0.45% per annum based upon the total net leverage ratio. As of December 31, 2022, the Company had $1.3 million of unamortized deferred debt issuance costs in its consolidated balance sheets. Debt Maturities As of December 31, 2022 2023 $ 6,250 2024 10,000 2025 47,500 Total $ 63,750 |
Common Stock and Stock-Based Co
Common Stock and Stock-Based Compensation | 12 Months Ended |
Dec. 31, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
Common Stock and Stock-Based Compensation | Common Stock and Stock-Based Compensation Common Stock On March 17, 2020, the Company, announced that its Board approved a new share repurchase program, or the Share Repurchase Program, providing for the repurchase of up to an aggregate of $160.0 million of the Company’s outstanding common stock. The Share Repurchase Program replaced the Company’s then existing share repurchase program, or the Previous Share Repurchase Program, which was announced on October 30, 2018 and was terminated in connection with the Board’s approval of the Share Repurchase Program. At termination, the Company had repurchased approximately $68.0 million of the Company’s outstanding common stock under the Previous Share Repurchase Program. Under the Share Repurchase Program, the Company is authorized to repurchase shares through open market purchases, privately-negotiated transactions, accelerated share repurchases or otherwise in accordance with applicable federal securities laws, including through Rule 10b5-1 trading plans and under Rule 10b-18 of the Exchange Act. The repurchases have no time limit and may be suspended or discontinued completely at any time. The specific timing and amount of repurchases varies based on available capital resources and other financial and operational performance, market conditions, securities law limitations, and other factors. The repurchases are made using the Company’s cash resources. On September 23, 2020, the Company's Board of Directors approved a $25.0 million accelerated share repurchase (“ASR”) transaction with JPMorgan Chase Bank, National Association (“JP Morgan”) as part of the Company’s existing $160.0 million share repurchase program. The specific number of shares to be repurchased pursuant to the ASR is based on the average of the daily volume weighted average share prices of the Company’s common stock, less a discount, during the term of the ASR program. Under the terms of the Company's agreement with JP Morgan, the Company paid $25.0 million to JP Morgan on September 24, 2020, and received 550,623 shares, representing the notional amount of the ASR, based on the average of the daily volume weighted average share prices of the Company’s common stock, less a discount, during the term of the ASR, which was $45.40. The ASR was completed in the fourth quarter of 2020. The Company determined the ASR contained a forward contract and therefore the Company recorded fair value adjustments on the accelerated share repurchase agreement in the amount of $3.0 million which was a loss recorded in Other expense on our consolidated statements of operations in the year ended December 31, 2020. As of December 31, 2022, the Company had repurchased an aggregate of 4,552,730 shares of common stock for an aggregate of $246.1 million pursuant to the Company’s share repurchase programs in effect since August 2016. We repurchased the following shares of common stock with cash resources: Year Ended December 31, 2022 2021 2020 Shares of common stock repurchased 441,108 429,446 774,489 Cash paid for r epurchases of common stock $ 18,004 $ 21,213 $ 34,999 Stock-Based Compensation In December 2007, the Company's board of directors approved the 2007 Incentive Compensation Plan (the "2007 Plan") enabling the Company to grant multiple stock-based awards to employees, directors and consultants, the most common being stock options and restricted stock awards. In November 2013, the Company's board of directors approved the 2014 Equity Incentive Plan (the "2014 Plan") which became effective on February 11, 2014. The 2007 Plan was terminated upon the effectiveness of the 2014 Plan and all shares available for issuance under the 2007 Plan were made available under the 2014 Plan. The 2014 Plan provides for the awards of incentive stock options, non-qualified stock options, restricted stock, restricted stock units and other stock-based awards. Awards generally vest equally over a period of four years from grant date. Vesting is accelerated under a change in control of the Company or in the event of death or disability to the recipient. In the event of termination, any unvested shares or options are forfeited. At the Company's annual meeting of stockholders held on August 4, 2015, the stockholders approved an amendment to the 2014 Plan to, among other things, increase the number of shares of common stock authorized for issuance thereunder by 500,000 shares. After accounting for such increase, and as of such amendment, the Company has reserved and made available 1,934,193 shares of common stock for issuance under the 2014 Plan. During the year ended December 31, 2018, the Company introduced a new long-term incentive program with the objective to better align the share-based awards granted to management with the Company's focus on improving total shareholder return over the long-term. The share-based awards granted under this long-term incentive program consist of time-based stock options, time-based restricted stock units ("RSUs") and performance-based stock units ("PSUs"). Stock Options The fair value of stock options granted to employees, directors, and consultants is estimated using the following assumptions: Year Ended December 31, 2022 2021 2020 Risk-free interest rate 1.47% - 4.3% 0.51% - 1.26% 0.37% - 1.65% Volatility 45.59% - 51.31% 52.87% - 60.02% 54.89% Expected term (in years) 5.50 - 6.08 years 5.50 - 6.08 years 5.50 - 6.08 years Expected dividend yield 0.0% 0.0% 0.0% The following table summarizes information about stock option activity related to the 2014 Plan: Number of Weighted Non- Exercisable Outstanding at December 31, 2020 3,331,890 $ 59.20 1,028,142 2,303,748 Granted 114,000 $ 46.74 Exercised (122,847) $ 27.64 Forfeited or expired (508,165) $ 62.00 Outstanding at December 31, 2021 2,814,878 $ 58.51 472,916 2,341,962 Granted 139,700 $ 44.15 Exercised (91,255) $ 25.74 Forfeited or expired (437,490) $ 62.89 Outstanding at December 31, 2022 2,425,833 $ 57.51 310,622 2,115,211 The weighted-average grant-date fair value of options granted during the year ended 2022, 2021, and 2020 was $20.49, $23.62, and $28.98, respectively. As of December 31, 2022, there was $4.9 million unrecognized stock-based compensation expense related to stock options that is expected to be recognized over a weighted average period of 1.8 y ears. The total intrinsic value of options exercised during the year ended December 31, 2022 was $1.7 million. The weighted average contractual terms of options outstanding as of December 31, 2022, 2021, and 2020 was 5.0, 5.2, and 6.1 years, respectively. The aggregate pre-tax intrinsic value of options outstanding as of December 31, 2022, 2021, and 2020 was $2.5 million, $13.8 million, and $11.6 million, respectively. RSUs Each vested time-based RSU represents the right of a holder to receive one of the Company’s common shares. The fair value of each RSU granted was estimated based on the trading price of the Company’s common shares on the date of grant. The following table summarizes information about RSU activity related to the 2014 Plan: Number of Weighted Non-vested at December 31, 2020 328,396 $ 53.09 Granted 106,600 $ 48.55 Vested (95,523) $ 52.26 Forfeited (76,167) $ 52.29 Non-vested at December 31, 2021 263,306 $ 51.77 Granted 148,000 $ 47.75 Vested (103,148) $ 51.39 Forfeited (38,995) $ 50.57 Non-vested at December 31, 2022 269,163 $ 49.88 As of December 31, 2022, there was $7.6 million of unrecognized stock-based compensation expense related to non-vested RSUs that is expected to be recognized over a weighted average period of 2.5 years. PSUs During the first quarter of 2022, we granted 228.2 thousand market condition PSUs based on our total shareholder return ("TSR") relative to the TSR of each member of the S&P Biotechnology Select Industry Index (the defined peer group) with a weighted-average grant date fair value of $70.45 for the CEO and $58.43 for other executives per respective PSU. The fair value of PSUs granted to employees was estimated using a Monte Carlo simulation model. Inputs used in the calculation include a risk-free interest rate of 1.6%, an expected volatility of 41%, contractual term of 3 years, and no expected dividend yield. The fair value of market condition PSUs granted to employees was estimated using a Monte Carlo simulation model. Inputs used in the calculation are described above. The fair value of performance condition PSUs granted to employees was estimated based on the trading price of our common stock on the date of grant adjusted for probability of achievement of the performance conditions as described above. We did not recognize any expense for performance based PSUs granted to employees based on our estimated probability of achievement as described above. During the first quarter of 2021, 97,750 market condition PSUs expired. We also granted 99,500 market condition PSUs based on our total shareholder return ("TSR") relative to the TSR of each member of the S&P Biotechnology Select Industry Index (the defined peer group) with a weighted-average grant date fair value of $71.09 per respective PSU. The fair value of PSUs granted to employees was estimated using a Monte Carlo simulation model. Inputs used in the calculation include a risk-free interest rate of 0.18%, an expected volatility of 44%, contractual term of 3 years, and no expected dividend yield. During the first quarter of 2021, we also granted 59,500 performance based (milestones) PSUs with grant date fair value of $49.32 using our closing stock price on the date of the grant. These PSUs will vest (if earned) from 0% to 200% of target number granted based on the achievement of one or more of three milestones related to i) regulatory approval of Fulvestrant ("EA-114"), ii) sales of PEMFEXY and; iii) sales of vasopressin, respectively. The contractual term of these awards is 3 years. We estimated 0% probability of achievement for the year ended December 31, 2022. The following table summarizes information about PSU activity related to the 2014 Plan: Number of Weighted Non-vested at December 31, 2020 97,750 $ 90.19 Granted 159,000 $ 62.94 Vested — $ — Forfeited (119,450) $ 84.90 Non-vested at December 31, 2021 137,300 $ 63.24 Granted 228,200 $ 63.93 Vested — $ — Forfeited (46,400) $ 59.27 Non-vested at December 31, 2022 319,100 $ 63.96 The Company recognized stock-based compensation in its consolidated statements of operations for the year ended December 31, 2022, 2021, and 2020 as follows: Year Ended December 31, 2022 2021 2020 Stock options $ 6,714 $ 11,521 $ 17,694 PSUs 4,665 2,729 1,635 RSUs 5,072 5,305 5,427 Stock-based compensation expense $ 16,451 $ 19,555 $ 24,756 Selling, general and administrative $ 14,001 $ 16,873 $ 22,074 Research and development 2,450 2,682 2,682 Stock-based compensation expense $ 16,451 $ 19,555 $ 24,756 |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income Taxes The components of our provision from income taxes is as follows: Year Ended December 31, 2022 2021 2020 Current: Federal $ 30,933 $ 6,912 $ 10,140 State 3,181 785 2,059 $ 34,114 $ 7,697 $ 12,199 Deferred: Federal (7,607) (3,030) (1,227) State (740) (588) (284) Foreign 24 — — $ (8,323) $ (3,618) $ (1,511) Provision for income taxes $ 25,791 $ 4,079 $ 10,688 The reconciliation of the statutory U.S. Federal income tax rate to the Company's effective income tax rate is as follows: Year Ended December 31, 2022 2021 2020 U.S. Federal statutory tax rate 21 % 21 % 21 % State income taxes, net of federal benefit 3 % (1) % 6 % Tax effect on stock option exercises, net of forfeitures 2 % (44) % 4 % R&D tax credits and Orphan Drug credits (1) % 31 % (2) % Limitation on executive compensation 3 % (60) % 9 % Change in valuation allowance 13 % (40) % 9 % Transaction costs 3 % — — Foreign rate differential (2) % 4 % (1) % Other — (1) % 1 % Effective tax rate 42 % (90) % 47 % The effective tax rate for the year ended December 31, 2022, reflects the impact of certain non-deductible executive compensation and the impact of certain non-deductible costs from the acquisition of Acacia, partially offset by credits for research and development activity. Deferred income taxes reflect the net tax effects of temporary differences between the carrying amount of assets and liabilities for financial reporting and the amounts used for income tax purposes. Significant components of the Company's deferred tax assets were as follows: December 31, 2022 2021 Deferred tax assets Net operating loss carryforward $ 46,996 $ 1,563 Stock based compensation 9,875 10,405 Other asset - equity investment with readily determined fair value 4,197 3,190 Inventories 3,405 2,123 Employee-related expenses 205 1,240 Intangible assets 4,559 4,207 Right-of-use liability 688 962 R&D tax credit carryforwards 471 329 Capitalized R&D 7,579 — Other 3,659 1,489 Total deferred tax assets 81,634 25,508 Deferred tax liabilities Installment sale - Malta 484 485 Prepaid expenses 59 45 Fixed assets 255 300 Lease liability 648 921 Intangible assets 18,530 — Inventory 2,981 — Other 247 — Total deferred tax liabilities 23,204 1,751 Valuation allowance (35,101) (4,959) Net deferred tax assets $ 23,329 $ 18,798 In July 2006, the Financial Accounting Standards Board (“FASB”) issued ASC 740-10, Uncertainty in Income Taxes, which defines the threshold for recognizing the benefits of tax-return positions in the financial statements as “more-likely-than-not” to be sustained by the taxing authorities. This statement also requires explicit disclosure requirements about a Company’s uncertainties related to their income tax position, including a detailed roll forward of tax benefits taken that do not qualify for financial statement recognition. The Company files income tax returns in the U.S. federal jurisdiction and several states. The Company is under audit by the Internal Revenue Service and three states tax jurisdiction as of December 31, 2022. Acacia Pharma Group and Acacia Pharma Inc. have not been historically audited by the IRS or HMRC. For Acacia Pharma Inc., the federal statute of limitations remains open for tax years 2015 onward. The statute remains open for five states, with 2018 being the earliest open year. For Acacia Pharma Group Plc and Acacia Pharma Limited, the 2021 tax year remains open until the end of 2023. The Company has no amount recorded for any unrecognized tax benefits as of December 31, 2022. The Company regularly evaluates its tax positions for additional unrecognized tax benefits and associated interest and penalties, if applicable. There are many factors that are considered when evaluating these tax positions including: interpretation of tax laws, recent tax litigation on a position, past audit or examination history, and subjective estimates and assumptions. As of December 31, 2022, the Company has a net operating loss ("NOL") carryforward in Malta of $5.5 million which has no expiration date and can be carried forward indefinitely until utilized. Acacia Pharma Group (U.K.) has net operating loss carryforwards of $167 million that will not expire. Acacia Pharma Inc. has net operating loss carryforwards of $6.5 million that will expire and $12 million that will not expire. As of December 31, 2022 the Company has not performed a 382 study to evaluate the use of the net operating losses of Acacia Pharma Inc. A full valuation allowance has been placed against both the federal and state loss carryforwards. During the year ended December 31, 2022, the valuation allowance for deferred tax assets increased by $30.1 million. This increase mainly relates to the acquisition of Acacia in which there are deferred tax assets in excess of deferred tax liabilities. The Company has determined that is it more likely than not that these assets will not be fully realized based on a current evaluation of expected future taxable income and Acacia is in a cumulative loss position. |
License and Collaboration Agree
License and Collaboration Agreements | 12 Months Ended |
Dec. 31, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
License and Collaboration Agreements | License and Collaboration Agreements License Agreements License agreement with Combioxin In August 2021, we entered into a license agreement with Combioxin, SA under which the Company was granted exclusive, worldwide development and commercialization rights to CAL02, a novel first-in-class anti-infective agent ready for Phase 2b/3 development for the treatment of severe pneumonia in combination with traditional antibacterial drugs. The Company will be solely responsible for the development, regulatory, manufacturing and commercialization activities of CAL02. Combioxin will assist the Company in transitioning the manufacturing and supply of CAL02 to the Company. Under the terms of the agreement, we paid $10 million as upfront license consideration that was expensed immediately as research and development and is reflected within the operating activities of the consolidated statements of cash flows as of December 31, 2021. The Company may pay to Combioxin up to $105 million upon achievement of certain development, regulatory and sales based milestone payments plus royalty payments at royalty rates ranging in low double digit percentages on the net sales of all products sold, subject to certain adjustments as provided in the agreement. The Company is also obligated to make certain payments based upon amounts received by sublicensees under the agreement. License agreement with AOP Orphan In August 2021, we entered into a licensing agreement with AOP Orphan Pharmaceuticals GmbH (“AOP Orphan”), a privately owned Austrian company devoted to the treatment of rare and special diseases, for the commercial rights to its product, landiolol in the United States. Landiolol, a leading hospital emergency use product, is currently approved in Europe for the treatment of non-compensatory sinus tachycardia and tachycardic supraventricular arrhythmias. We supported the submission of a new drug application (“NDA”) in the second quarter of 2022 by AOP Orphan to the FDA seeking approval for landiolol for the short term reduction of ventricular rate in patients with supraventricular tachycardia (“SVT”) , including atrial fibrillation and atrial flutter. Under the terms of the agreement, we paid a $5 million upfront license consideration that was expensed immediately as research and development and is reflected within the operating activities of the consolidated statements of cash flows as of December 31, 2021 . We may pay to AOP Orphan up to $25 million upon achievement of certain regulatory milestone payments plus profit share payments, subject to certain adjustments as provided in the agreement. We also entered into a supply agreement at the same time as the licensing agreement. Collaboration with Tyme (now merged with Syros) On January 7, 2020, Tyme Technologies, Inc. (“Tyme”) and we announced a strategic collaboration to advance SM-88, an oral product candidate for the treatment of patients with cancer. SM-88 is an investigational agent in two Phase II studies, one for pancreatic cancer and another for prostate cancer. In September 2022, Syros announced the closing of its merger with Tyme pursuant to which Syros acquired Tyme. The combined company is known as Syros going forward. Under the terms of a related co-promotion agreement, we would be responsible for 25% of the promotional sales effort of SM-88 and would receive 15% royalty on the net revenues of SM-88 in the United States. Syros is responsible for clinical development, regulatory approval, commercial strategy, marketing, reimbursement and manufacturing of SM-88. Syros retains the remaining 85% of net U.S. revenues and reserves the right to repurchase our U.S. co-promotion right for $200.0 million. Our equity investment in Syros is included in Other assets on our consolidated balance sheet. For the years ended December 31, 2022, 2021, and 2020, the fair value adjustments for the equity investment were a loss of $4.5 million, a loss of $6.2 million and a loss of $5.3 million, respectively. These adjustments were recorded in Other (expense) income on our consolidated statements of operations. |
Commitments
Commitments | 12 Months Ended |
Dec. 31, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments | Commitments Our future material contractual obligations include the following: Obligation Total 2023 2024 2025 Beyond Operating leases (1) $ 3,207 $ 1,672 $ 1,122 $ 413 $ — Credit facility and Term loans (2) 63,750 6,250 10,000 47,500 — Investment in Enalare (3) 12,500 12,500 — — — Purchase obligations (4) 87,501 87,501 — — — Total obligations $ 166,958 $ 107,923 $ 11,122 $ 47,913 $ — (1) We lease our corporate office location. The term of our existing lease expires on June 30, 2025. We also lease our lab space under a lease agreement through April 2024, office space located in Indianapolis, Indiana through November 2023, and an office space in Palm Beach Gardens, Florida, through October 31, 2024. Rental expense was $1,507, $1,407, and $1,323, for the years ended December 31, 2022, 2021, and 2020, respectively. The remaining future lease payments under the operating leases, exclusive of any renewal option periods, are $3,207 as of December 31, 2022, payable monthly. December 31, 2022 Total operating lease payments $ 3,207 Less: imputed interest (165) Total lease liabilities $ 3,042 (2) Refer to Note 6, “Debt” for further information regarding our Credit Agreement and Term Loans. (3) We invested $12.5 million in Enalare at the time of entering the agreement in August 2022, and we are contractually obligated to invest another $12.5 million six months after August 2022. Refer to No te 11, Investment in Enalare Therapeutics Inc. for further details. (4) As of December 31, 2022, the Company has purchase obligations in the amount of $87.5 million which represents the contractual commitments under contract manufacturing and supply agreements with suppliers. The obligation under the supply agreement is primarily for finished product, inventory, and research and development. |
Investment in Enalare Therapeut
Investment in Enalare Therapeutics Inc. | 12 Months Ended |
Dec. 31, 2022 | |
Equity Method Investments and Joint Ventures [Abstract] | |
Investment in Enalare Therapeutics Inc. | Investment in Enalare Therapeutics Inc. On August 8, 2022, we and Enalare entered into a Securities Purchase Agreement ("SPA"), pursuant to the terms of the SPA, we invested $12.5 million in August 2022 and an additional $12.5 million in February 2023. We may also invest an additional $30 million, subject to the completion of certain development milestones. Concurrently with the execution of the SPA, we also entered into a Security Purchase Option Agreement ("SPOA"), pursuant to which we were granted an option to acquire all of the remaining outstanding shares of Enalare, subject to the terms and conditions of the agreement. The term of the Purchase Option (the "Option Period") commenced on August 8, 2022 and will end upon the earlier of (x) 90 days following the FDA communication of proceed to clinical for a Phase 3 clinical study for a Product Candidate or (y) June 30, 2027. Enalare shall not initiate Phase 3 pivotal studies prior to the end of the Option Period and we shall have reasonable access to all relevant data and documents following the Phase 3 Milestone (as defined in the Option Agreement). We recorded an equity investment in the amount of $8.4 million, an asset related to the acquisition right in the amount of $8.1 million and a forward liability of $4.1 million related to the contractual obligation to invest another $12.5 million within six months from August 2022 in accordance with ASC 321 Investments – Equity Securities . We used a probability factor to value the asset related to the acquired acquisition rights based on management's best estimate, including the probability of completion of certain development milestones. The equity stake was accounted for as an non-RDFV investment. The equity investment, acquisition right, and forward liability was reported at fair value as of December 31, 2022. Summarized financial information of our investment and equity ownership in Enalare for the year ended December 31, 2022 is presented below: Beginning balance as of January 1, 2022 Additions during period Adjustments Ending balance as of December 31, 2022 Non-RDFV Investment $ — $ 8,438 $ — $ 8,438 Acquisition Rights (Other assets) — 8,125 — 8,125 Forward Liability (Accrued expenses and other liabilities) — (4,063) — (4,063) Total, net $ — $ 12,500 $ — $ 12,500 |
Intangible Assets, Net
Intangible Assets, Net | 12 Months Ended |
Dec. 31, 2022 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Intangible Assets, Net | Intangible Assets, Net The gross carrying amounts and net book value of our intangible assets are as follows: December 31, 2022 Useful Life (In Years) Gross Carrying Amount Accumulated Amortization Accumulated Impairment Charges Net Book Value BARHEMSYS intangible (1) 9 $ 70,319 $ (4,462) $ — $ 65,857 BYFAVO intangible (1) 9 33,714 (1,989) — 31,725 Ryanodex intangible (2) 9 15,000 (7,402) — 7,598 PEMFEXY intangible (3) 2 15,000 (1,888) — 13,112 Vasopressin Milestone (4) 1 750 (715) — 35 Total $ 134,783 $ (16,456) $ — $ 118,327 December 31, 2021 Useful Life (In Years) Gross Carrying Amount Accumulated Amortization Accumulated Impairment Charge Net Book Value Ryanodex intangible (2) 9 $ 15,000 $ (5,079) $ — $ 9,921 Developed technology 5 8,100 (8,100) — — Vasopressin Milestone (4) 1 750 — — 750 Total $ 23,850 $ (13,179) $ — $ 10,671 (1) Represents intangible assets acquired in the Acacia Pharma acquisition as detailed in Note 15. (2) Represents a one-time payment made to reduce the royalties payable to a third party on Ryanodex net sales. (3) Represents a one-time payment made to reduce the royalties payable to a third party on PEMFEXY net sales. (4) Represents milestone paid to a third party upon FDA approval of vasopressin. Amortization expense amounted to $11.4 million, $3.0 million, and $2.7 million, for the year ended December 31, 2022, 2021, and 2020, respectively. Estimated Useful Lives The Company reviews the estimated useful lives of its intangible assets on a periodic basis. During 2021, the review indicated that the actual life of the Ryanodex intangible asset was shorter than the estimated useful life used for amortization purposes in the Company’s financial statements. As a result, the estimated useful life of the Ryanodex related intangible assets was shortened from 2036 to 2025. The change in the estimated useful life is considered a change in accounting estimate and resulted in changes to the Company's amortization expense prospectively. As of December 31, 2021, the net carrying value of the Ryanodex related intangible assets was $9.9 million. The effect of this change in estimate increased the 2021 amortization expense by $0.4 million. Impairment Assessment The Company reviews the recoverability of its finite-lived intangible assets and long-lived assets for indicators of impairments. Events or circumstances that may require an impairment assessment include negative clinical trial results, a significant decrease in the market price of the asset, or a significant adverse change in legal factors or the manner in which the asset is used. If such indicators are present, the Company assess the recoverability of affected assets by determining if the carrying value of such assets is less than the sum of the undiscounted future cash flows of the assets. If such assets are found to not be recoverable, the Company measures the amount of the impairment by comparing to the carrying value of the assets to the fair value of the assets. The Company determined that no indicators of impairment of finite-lived intangible assets or long-lived assets existed at December 31, 2022 and 2021. Estimated Amortization Expense for Intangible Assets Based on definite-lived intangible assets recorded as of December 31, 2022, and assuming that the underlying assets will not be impaired and that the Company will not change the expected lives of the assets, future amortization expenses are estimated as follows: Estimated Amortization Expense Year Ending December 31, 2023 21,916 2024 19,770 2025 13,908 2026 11,606 2027 11,606 Thereafter 39,521 Total estimated amortization expense $ 118,327 |
Legal Proceedings
Legal Proceedings | 12 Months Ended |
Dec. 31, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Legal Proceedings | Legal ProceedingsIn addition to the below legal proceedings, from time to time, we may be a party to litigation and subject to claims incident to the ordinary course of business. Although the results of litigation and claims cannot be predicted with certainty, we currently believe that the final outcome of these ordinary course matters, or matters discussed below, will not have a material adverse effect on our business nor have we recorded any loss in connection with these matters because we believe that loss is neither probable nor estimable. Regardless of the outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of management resources and other factors. Commercial Litigation Curia’s Claims in Arbitration and Litigation On January 23, 2023, Curia Global, Inc. (“Curia”) filed a demand for arbitration against Eagle (“the Company”) with the American Arbitration Association (the “Arbitration”). Curia makes claims for breach of contract, account stated and breach of the implied covenant of good faith and fair dealing arising from the parties’ supply agreement relating to the vasopressin product. Curia seeks damages in excess of $76.7 million. On February 28, 2023, Curia and its subsidiary Curia New Mexico, LLC filed an action against the Company in New York State Court, making claims for breach of contract and account stated arising from the parties’ supply agreement relating to the PEMFEXY product (the “NY Action”). Curia seeks damages in excess of $4.2 million. The Company believes it has meritorious defenses to all of Curia’s claims and intends to defend this Arbitration and the NY Action vigorously. The Company cannot assure that it will be successful in defending against such claims. In Re: Taxotere (Docetaxel) Beginning in May 2022, the Company was named as a defendant, among various other manufacturers, in several product liability suits that are consolidated in the U.S. District Court for the Eastern District of Louisiana as part of MDL 3023 (Civil Action No 22-1347 H(5)), or the Multidistrict Litigation. The claims are for personal injuries allegedly arising out of the use of docetaxel. Patent Litigation Eagle Pharmaceuticals, Inc., et al. v. Slayback Pharma Limited Liability Company; Eagle Pharmaceuticals, Inc., et al. v. Apotex Inc. and Apotex Corp.; Eagle Pharmaceuticals, Inc., et al. v. Fresenius Kabi USA, LLC; Eagle Pharmaceuticals, Inc., et al. v. Mylan Laboratories Limited; Eagle Pharmaceuticals, Inc. et al. v. Hospira, Inc; Eagle Pharmaceuticals, Inc. et al. v. Lupin, Ltd. and Lupin Pharmaceuticals, Inc.; Teva Pharmaceuticals Int’l GmbH et al v. Aurobindo Pharma Ltd., Aurobindo Pharma USA, Inc., and Eugia Pharma Specialities Ltd.; Teva Pharmaceuticals Int’l GmbH et al v. Accord Healthcare Inc., Accord Healthcare Ltd., and Intas Pharmaceuticals Ltd.; Teva Pharmaceuticals Int’l GmbH et al v. Dr. Reddy’s Laboratories, Ltd., and Dr. Reddy’s Laboratories, Inc. - (Bendeka ® ) Bendeka, which contains bendamustine hydrochloride, is an alkylating drug that is indicated for the treatment of patients with chronic lymphocytic leukemia, as well as for the treatment of patients with indolent B-cell non-Hodgkin's lymphoma that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. Slayback Pharma Limited Liability Company (“Slayback”), Apotex Inc. and Apotex Corp. (“Apotex”), Fresenius Kabi USA, LLC (“Fresenius”), Mylan Laboratories Limited (“Mylan”), Lupin, Ltd. and Lupin Pharmaceuticals, Inc. (“Lupin”), and Aurobindo Pharma, Ltd, Aurobindo Pharma USA, Inc., and Eugia Pharma Specialities Ltd (“Aurobindo”) have filed Abbreviated New Drug Applications (“ANDA’s”) referencing Bendeka ® that include challenges to one or more of the Bendeka ® Orange Book-listed patents. Hospira, Inc. (“Hospira”) filed a 505(b)(2) NDA. We, Cephalon, Inc. and/or Teva Pharmaceuticals International GMBH (together the “Patentees”), filed separate suits against Slayback, Apotex, Fresenius, Mylan, Hospira, Lupin, and Aurobindo in the United States District Court for the District of Delaware on August 16, 2017 (Slayback (“Slayback I”)), August 18, 2017 (Apotex), August 24, 2017 (Fresenius), December 12, 2017 (Mylan), January 19, 2018 (Slayback (“Slayback II”)), July 19, 2018 (Hospira), and July 2, 2019 (Lupin) and May 11, 2020 (Aurobindo). In these Complaints, the Patentees allege infringement of the challenged patents, namely U.S. Patent Nos. 8,791,270 and 9,572,887 against Slayback (Slayback I and Slayback II), and of U.S. Patent Nos. 8,609,707, 8,791,270, 9,000,021, 9,034,908, 9,144,568, 9,265,831, 9,572,796, 9,572,797, 9,572,887, 9,579,384, 9,597,397, 9,597,398, 9,597,399 against Fresenius, Apotex, and Mylan, and of U.S. Patent Nos. 9,572,887, 10,010,533, 9,034,908, 9,144,568, 9,597,397, 9,597,398, 9,597,399, 9,000,021, 9,579,384 against Hospira, and of U.S. Patent Nos. 8,609,707, 9,000,021, 9,034,908, 9,144,568, 9,265,831, 9,572,796, 9,572,797, 9,572,887, 9,579,384, 9,597,397, 9,597,398, 9,597,399, 10,010,533, and 10,052,385 against Lupin and of U.S. Patent Nos. 8,609,707, 9,265,831, 9,572,796, 9,572,797, 9,034,908, 9,144,568, 9,572,887, 9,597,397, 9,597,398, 9,597,399, 9,000,021, 9,579,384, 10,010,533, and 10,052,385 against Aurobindo. The parties stipulated to dismiss without prejudice U.S. Patent No. 8,791,270 as to Apotex, Fresenius and Mylan on July 24, 2018, August 2, 2018, and August 3, 2018, respectively. Slayback, Apotex, Fresenius, and Mylan answered their Complaints and some filed various counterclaims on September 29, 2017 (Slayback I), February 12, 2018 (Slayback II), November 27, 2017, September 15, 2017, and February 14, 2018, respectively. The Patentees answered the Slayback I, Slayback II, Fresenius, and Apotex counterclaims on October 20, 2017, March 5, 2018, October 6, 2017, and December 18, 2017, respectively. On October 15, 2018, the Patentees filed a suit against Fresenius and Mylan in the United States District Court for the District of Delaware, alleging patent infringement of U.S. Patent Nos. 10,010,533 and 10,052,385. The Slayback I, Slayback II, Apotex, Fresenius and Mylan cases have been consolidated for all purposes (the “Consolidated Bendeka Litigation”), and a bench trial in these cases was held September 9-19, 2019. On April 27, 2020, the district court held that the asserted patents are valid and infringed by Slayback, Apotex, Fresenius and Mylan. On July 6, 2020, the district court entered a final judgment reflecting this decision, stating that pursuant to 35 U.S.C. § 271(e)(4)(A), the FDA shall not approve Apotex’s, Fresenius’s, Mylan’s, or Slayback’s ANDA products on a date which is earlier than January 28, 2031, and enjoining Apotex, Fresenius, Mylan, and Slayback from commercially manufacturing, using, offering to sell, or selling within the US or importing into the US, their ANDA products before that date. On August 4, 2020, Apotex, Fresenius, and Mylan appealed this final judgment, and filed their opening briefs on November 4, 2020. Plaintiffs’ responsive appeal brief was filed on February 12, 2021. Defendants’ reply briefs were filed April 5, 2021. On August 2, 2021, Fresenius’s appeal was dismissed pursuant to a settlement agreement reached with Patentees. Oral argument for the remaining defendants occurred on August 3, 2021. On August 13, 2021, the appeals court affirmed the trial court’s decision. The mandate was issued on October 22, 2021. Apotex filed a petition for certiorari on December 14, 2021, which the Supreme Court denied on February 22, 2022. Hospira filed a motion to dismiss, which was fully briefed on November 16, 2018. On December 16, 2019, the United States District Court for the District of Delaware denied Hospira’s motion to dismiss with respect to U.S. Patent No. 9,572,887 and granted that motion with respect to the remaining patents. On December 15, 2020, the Court held a claim construction hearing, ruling in our favor on all claim terms. Fact discovery closed on April 1, 2021. Expert discovery ended on February 10, 2022. The parties reached a settlement on April 19, 2022, resulting in dismissal of the action. Patentees filed suit against Hospira, Inc. on November 16, 2021. Patentees have asserted U.S. Patent No. 11,103,483. Hospira filed its Answer on December 8, 2021. The parties reached a settlement on April 19, 2022, resulting in dismissal of the action. On March 10, 2020, the parties filed a stipulation and order of dismissal without prejudice as to Lupin, which the Court entered March 11, 2020. Aurobindo answered the Complaint on July 20, 2020. The parties exchanged initial disclosures on December 11, 2020. Plaintiffs provided their infringement contentions on March 12, 2021. On October 20, 2021 the Court entered a stipulation of dismissal based on a settlement between the parties. Patentees filed suit against Dr. Reddy’s Laboratories on May 13, 2021. Patentees have asserted U.S. Patent Nos. 8,609,707, 9,265,831, 9,572,796, 9,572,797, 9,034,908, 9,144,568, 9,572,887, 9,597,397, 9,597,398, 9,597,399, 9,000,021, 9,579,384, 10,010,533, and 10,052,385. Dr. Reddy’s answer was filed August 16, 2021. On December 27, 2021, Dr. Reddy’s moved for judgment on the pleadings, seeking a dismissal of all patents except the ‘887 patent. On January 27, 2022, the Court entered an agreed stipulation by the parties dismissing all patents except the ‘887. On February 8, 2022, consistent with that stipulation, Patentees filed an Amended Complaint removing the dismissed patents and adding U.S. Patent No 11,103,483. Dr. Reddy’s filed its Answer and Counterclaims to that Amended Complaint on February 22, 2022. Patentees’ filed their Counterclaim Answer on March 15, 2022. A claim construction hearing was held on September 15, 2022, and the case is set for trial on May 1, 2023. Patentees filed suit against Accord Healthcare on June 29, 2021. Patentees have asserted U.S. Patent Nos. 8,609,707, 9,265,831, 9,572,796, 9,572,797, 9,034,908, 9,144,568, 9,572,887, 9,597,397, 9,597,398, 9,597,399, 9,000,021, 9,579,384, 10,010,533, and 10,052,385. On January 13, 2022, Accord filed a Motion to Dismiss for failure to state a claim. On January 26, 2022, Patentees filed a First Amended Complaint, removing all patents except the ‘887 patent and additionally asserting U.S. Patent No. 11,103,483. Accord filed its Answer and Counterclaims to that Amended Complaint on February 10, 2022. On February 28, 2022, Patentees filed their Answer to Accord’s Counterclaims. On March 29, 2022, the Court entered a schedule and consolidated this case with the above Dr. Reddy’s case. The parties reached a settlement on December 9, 2022, resulting in dismissal of the action. Eagle Pharmaceuticals, Inc. v. Slayback Pharma Limited Liability Company - (Belrapzo®) Slayback filed an ANDA referencing Eagle's Belrapzo NDA. Slayback’s ANDA includes challenges to one or more of the Belrapzo Orange Book-listed patents. On September 20, 2018, the Company filed a suit against Slayback in the United States District Court for the District of Delaware, alleging patent infringement of U.S. Patent Nos. 8,609,707, 9,265,831, 9,572,796, 9,572,797 and 10,010,533. On October 10, 2018, Slayback answered the Complaint and filed various counterclaims. On October 31, 2018, the Company answered Slayback’s counterclaims. Pursuant to a stipulation between the parties, Slayback is bound by any final judgment entered in the Consolidated Bendeka Litigation. This case is currently stayed. On January 24, 2023, the parties submitted a proposed judgment consistent with that stipulation, which the Court entered on January 25, 2023. Eagle Pharmaceuticals, Inc. v. Slayback Pharma Limited Liability Company, Apotex, Inc. and Apotex Corp., Celerity Pharmaceuticals, LLC - (Belrapzo ® ) Slayback, Apotex, and Celerity Pharmaceuticals, LLC (“Celerity”) filed NDAs referencing Eagle’s Belrapzo NDA. The Company filed suits against Slayback, Apotex, and Celerity in the United States District Court for the District of Delaware on August 31, 2021 (Slayback and Apotex) and on January 11, 2022 (Celerity) alleging infringement of U.S. Patent No. 11,103,483. On September 22, 2021, both Slayback and Apotex filed their Answers. On September 29, 2022, trial was held in the suit against Slayback and Apotex. On October 25, 2022, the Court issued its opinion and entered a judgment of non-infringement with respect to Slayback and Apotex. The Company filed a notice of appeal on October 26, 2022. The appeal is ongoing. On February 2, 2022, Celerity moved to dismiss the pending complaint. In response, the Company filed an Amended Complaint on March 1, 2022. Celerity filed its answer to the Company’s Amended Complaint on March 22, 2022. On April 19, 2022, Celerity moved for judgment on the pleadings. On June 24, 2022, the Court entered a schedule coordinated with the above Accord and Dr. Reddy’s cases. A claim construction hearing was held on September 15, 2022. On October 28, 2022, the parties filed a proposed stipulated judgment of non-infringement, which the Court entered that day. Eagle Pharmaceuticals, Inc. v. Accord Healthcare Inc., Accord Healthcare Ltd., and Intas Pharmaceuticals Ltd. - (Belrapzo ® ) Accord filed an NDA referencing Eagle's Belrapzo NDA. Accord’s NDA includes challenges to one or more of the Belrapzo Orange Book-listed patents. On May 27, 2022, the Company filed a suit against Accord in the United States District Court for the District of Delaware, alleging patent infringement of U.S. Patent Nos. 8,609,707, 9,265,831, 9,572,796, 9,572,797, 10,010,533, and 11,103,483. On July 6, 2022 the Company filed a First Amended Complaint, removing all patents except the ‘483 patent. Accord filed its Answer and Counterclaims on July 20, 2022. The Company filed its Answer to Accord’s Counterclaims August 9, 2022. On September 20, 2022, the Court entered a schedule consolidating this case with the above Accord and Dr. Reddy’s cases. On November 18, 2022, the parties filed a proposed stipulated judgment of non-infringement, which was entered by the Court on November 21, 2022. Eagle Pharmaceuticals, Inc. & SymBio Pharmaceuticals Ltd. v. Towa Pharmaceutical Co., Ltd. ; Eagle Pharmaceuticals, Inc. & SymBio Pharmaceuticals Ltd. v. Pfizer Japan Inc. - (Treakisym) The Company, together with its exclusive licensee SymBio Pharmaceuticals Ltd. (“SymBio”), initiated lawsuits in the Tokyo District Court against Towa Pharmaceutical Co., Ltd. (“Towa”) on December 16, 2022 and against Pfizer Japan Inc. (“Pfizer”) on December 26, 2022 for patent infringement of Eagle’s Japanese Patent No. 6570601 for TREAKISYM injection solution 100 mg/4mL (bendamustine hydrochloride hydrate). In their complaint, Eagle and SymBio sought remedies that include an injunction against the manufacture or sale of Towa and Pfizer’s generic products and compensation for damages. Towa and Pfizer answered the complaint. A first hearing occurred before the Tokyo District Court in the Towa infringement action on February 6, 2023, in which the Court determined a timetable for the case. In the Towa action, the parties will give technical presentation before the judges and experts on October 30, 2023, and the court will reveal its view on infringement and validity on November 20, 2023. A first hearing is also scheduled before the Tokyo District Court in the Pfizer infringement action on April 25, 2023. Par Pharmaceutical, Inc. et al. v. Eagle Pharmaceuticals, Inc. (Vasopressin) On May 31, 2018, Par Pharmaceutical, Inc., Par Sterile Products, LLC, and Endo Par Innovation Company, LLC (together, “Par”) filed suit against the Company in the United States District Court for the District of Delaware. Par alleged patent infringement based on the filing of the Company’s ANDA seeking approval to manufacture and sell the Company’s vasopressin product. The Company’s vasopressin product is an alternative to Vasostrict, which is indicated to increase blood pressure in adults with vasodilatory shock (e.g., post-cardiotomy or sepsis) who remain hypotensive despite fluids and catecholamines. The Company answered the complaint on August 6, 2018, and filed an amended answer and counterclaims on October 30, 2019. |
Convertible Promissory Note
Convertible Promissory Note | 12 Months Ended |
Dec. 31, 2022 | |
Investments, Debt and Equity Securities [Abstract] | |
Convertible Promissory Note | Convertible Promissory Note During the first quarter of 2021, we invested $5 million in a convertible promissory note (the "note") of a privately held clinical-stage biotechnology company (the "issuer"). The note bore an 8% annual interest rate and had an 18-month term. The issuer is not required to make any principal or interest payments until the end of the term. The note, along with any accrued interest, may automatically convert into equity securities of the issuer under either a financing event or a change in control event as defined in the convertible promissory note agreement. The issuer's product development efforts could encounter technical or other difficulties that could increase their development costs more than expected. The issuer did not have sufficient cash and was unable to obtain additional capital to be able to repay the convertible promissory note with accrued interest at the end of the term. During 2022, we impaired the note, accrued interest, as well as the value of the embedded derivative related to the equity conversion feature contained in the note. The following table summarizes the amounts recorded and activity during the year ended December 31, 2022; December 31, 2021 Fair Value Adjustments to the note Accretion of Discount Estimated Credit Loss Interest Income Fair Value Adjustment to Embedded Derivative December 31, 2022 Fair value of the note $ 4,906 $ (4,906) $ — $ — $ — $ — $ — Discount on the note (127) — 127 — — — — Estimated Credit Loss (758) — — 758 — — — Convertible Promissory Note, net $ 4,021 $ (4,906) $ 127 $ 758 $ — $ — $ — Embedded Derivative $ 962 $ — $ — $ — $ — $ (962) $ — Interest Receivable $ 329 $ — $ — $ (329) $ — $ — $ — Total in Other Current Assets $ 5,312 $ (4,906) $ 127 $ 429 $ — $ (962) $ — Initial Fair Value Adjustments to the note Accretion of Discount Estimated Credit Loss Interest Income Fair Value Adjustment to Embedded Derivative December 31, 2021 Fair value of the note $ 5,000 $ (94) $ — $ — $ — $ — $ 4,906 Discount on the note (276) — 149 — — — (127) Estimated Credit Loss — — — (758) — — (758) Convertible Promissory Note, net $ 4,724 $ (94) $ 149 $ (758) $ — $ — $ 4,021 Embedded Derivative $ 276 $ — $ — $ — $ — $ 686 $ 962 Interest Receivable $ — $ — $ — $ — $ 329 $ — $ 329 Total in Other Current Assets $ 5,000 $ (94) $ 149 $ (758) $ 329 $ 686 $ 5,312 |
Business Acquisition
Business Acquisition | 12 Months Ended |
Dec. 31, 2022 | |
Business Combination and Asset Acquisition [Abstract] | |
Business Acquisition | Business Acquisition On June 9, 2022, we completed our acquisition of the entire issued share capital of Acacia Pharma for cash consideration and common stock totaling 94.7 million euros, the equivalent of 0.90 euros per share, and an aggregate of 516,024 shares of our common stock. Each shareholder of Acacia Pharma received 0.68 euros in cash and 0.0049 shares of our common stock. Acacia Pharma is a hospital pharmaceutical company focused on the development and commercialization of new products aimed at improving the care of patients undergoing significant treatments such as surgery and other invasive procedures. The transaction was entered to expand our current portfolio of FDA approved hospital products with the addition of BARHEMSYS and BYFAVO. We evaluated the Business Acquisition under ASC 805, Business Combinations and ASU 2017-01, Business Combinations: Clarifying the Definition of a Business. We concluded that substantially all of the fair value of the gross assets acquired is not concentrated in a single identifiable asset or a group of similar identifiable assets. The transaction does not pass the screen test and thus management performed an assessment to determine if the acquired entities met the definition of a business. For the assessment, management considered whether it has acquired (i) inputs, (ii) processes, and (iii) outputs. Under ASC 805, to be considered a business, a set of activities and assets is required to have only the first two of the three elements, which together are or will be used in the future to create outputs. Management determined that the acquired entities met the definition of a business since we acquired inputs, processes capable of producing outputs and outputs. Therefore, the acquisition has been accounted for under the acquisition method of accounting. Under the acquisition method, the total purchase price of the acquisition is allocated to the net tangible and identifiable intangible assets acquired and liabilities assumed based on the fair values as of the date of the acquisition. The acquisition-date fair value of the consideration totaled $100.4 million, summariz ed as follows (in thousands): Fair Value of Consideration Cash consideration $ 76,708 Fair value of Eagle common stock issued 23,645 $ 100,353 The purchase price allocation resulted in the amounts being allocated to the assets acquired and liabilities assumed at the acquisition date based upon their respective fair values summarized below. The determination of fair value was finalized in the fourth quarter of 2022. During the year ended December 31, 2022, we recorded certain measurement period adjustments, which are summarized below. The impact of these measurement period adjustments were recorded as an increase to goodwill, increasing the goodwill balance to $5.3 million. The following table presents the allocation of the purchase price to the estimated fair values of the assets acquired and liabilities assumed as of the acquisition date (in thousands): Preliminary Purchase Price Allocation as of acquisition date Measurement Period Adjustments Purchase Price Allocation Cash $ 2,556 $ — $ 2,556 Net working capital, excluding cash (2,158) — (2,158) Inventory 26,942 (9,394) 17,548 Intangible assets 104,000 4,000 108,000 Debt (28,503) 1,844 (26,659) Deferred tax liability, net (4,536) 311 (4,225) Fair value of net assets acquired 98,301 (3,239) 95,062 Goodwill 3,315 1,976 5,291 $ 101,616 $ (1,263) $ 100,353 The estimated fair value of acquired intangible assets was determined using the "income approach," which is a valuation technique that provides an estimate of the fair value of an asset based on market participant expectations of the cash flows an asset would generate over its remaining useful life. The inventory acquired was valued at expected profit margins for the acquired products. The fair value of working capital acquired approximates its book value. The fair value of debt acquired was based on the present value of future cash outflows using the net present value approach and applying an interest rate that is considered to be a market participant equivalent rate. The assumptions, including the expected projected cash flows, utilized in the purchase price allocation and in determining the purchase price were based on management's best estimates as of the close date of the acquisition on June 9, 2022. Some of the more significant assumptions inherent in the development of the intangible asset valuations included the estimated net cash flow for each year for each asset (including relevant marker size and market share), the appropriate discount rate to select in order to measure the risk inherent in each future cash flow stream, as well as other factors. We incurred approximately $12.6 million in acquisition-related expenses, which were included in selling, general and administrative expenses in the consolidated statements of operations for the year ended December 31, 2022. These expenses primarily consist of legal fees and success fees paid to third party advisors. The results of Acacia Pharma operations have been included in our consolidated statements of operations beginning on the acquisition date. The acquired business contributed revenues of $1.6 million and net loss of $15.8 million to us for the period from June 9, 2022 to December 31, 2022. The goodwill recorded related to the acquisition is the excess of the fair value of the consideration transferred by the acquirer over the fair value of the net identifiable assets acquired and liabilities assumed at the date of acquisition. The goodwill recorded is not deductible for tax purposes. Pro Forma Financial Information: The following table provides unaudited pro forma financial information for the years ended December 31, 2022 and 2021 as if the acquisition of Acacia Pharma had occurred as of January 1, 2021: Year Ended 2022 2021 Total revenue $ 317,792 $ 172,709 Net income (loss) $ 19,189 $ (92,886) These amounts have been calculated after applying our accounting policies. The pro forma results above include the impact of the following adjustments, as necessary: additional amortization expense relating to assets acquired; interest and other financing costs relating to the acquisition transaction; and the elimination of one-time or nonrecurring items. The one-time or nonrecurring items eliminated were primarily comprised of inventory fair value step-up adjustments; transaction costs, as well as certain Acacia-related share based payment charges and employee compensation expenses. The pro forma results do not include any anticipated cost savings or other effects of the planned integration of Acacia Pharma. Accordingly, the pro forma results above are not necessarily indicative of the results that would have been if the acquisition had occurred on the dates indicated, nor are the pro forma results indicative of results which may occur in the future. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Policies [Abstract] | |
Business combinations and asset acquisitions | Business combinations and Asset Acquisitions The Company evaluates acquisitions of assets and other similar transactions to assess whether or not the transaction should be accounted for as a business combination or asset acquisition by first applying a screen test to determine if substantially all of the fair value of the gross assets acquired is concentrated in a single identifiable asset or group of similar identifiable assets. If the screen test is met, the transaction is accounted for as an asset acquisition. If the screen test is not met, further determination is required as to whether or not the Company has acquired inputs and processes that have the ability to create outputs, which would meet the requirements of a business. If determined to be a business combination, the Company accounts for the transaction under the acquisition method of accounting as indicated in ASU 2017-01, Business Combinations (Topic 805): Clarifying the Definition of a Business, which requires the acquiring entity in a business combination to recognize the fair value of all assets acquired, liabilities assumed, and any non-controlling interest in the acquiree and establishes the acquisition date as the fair value measurement point. Accordingly, the Company recognizes assets acquired and liabilities assumed in business combinations, including contingent assets and liabilities, and non-controlling interest in the acquiree based on the fair value estimates as of the date of acquisition. In accordance with ASC 805, Business Combinations, the Company recognizes and measures goodwill as of the acquisition date, as the excess of the fair value of the consideration paid over the fair value of the identified net assets acquired. If determined to be an asset acquisition, the Company accounts for the transaction under ASC 805-50, which requires the acquiring entity in an asset acquisition to recognize assets acquired and liabilities assumed based on the cost to the acquiring entity on a relative fair value basis, which includes transaction costs in addition to consideration given. No gain or loss is recognized as of the date of acquisition unless the fair value of non-cash assets given as consideration differs from the assets’ carrying amounts on the acquiring entity’s books. Consideration transferred that is non-cash will be measured based on either the cost (which shall be measured based on the fair value of the consideration given) or the fair value of the assets acquired and liabilities assumed, whichever is more reliably measurable. Goodwill is not recognized in an asset acquisition and any excess consideration transferred over the fair value of the net assets acquired is allocated to the identifiable assets based on relative fair values. |
Use of Estimates | Use of Estimates These financial statements are presented in U.S. dollars and are prepared in accordance with U.S. GAAP. The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements including disclosure of contingent assets and contingent liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period and accompanying notes. Our critical accounting policies are those that are both most important to our financial condition and results of operations and require the most difficult, subjective or complex judgments on the part of management in their application, often as a result of the need to make estimates about the effect of matters that are inherently uncertain. As of the date of issuance of these financial statements, we are not aware of any specific event or circumstance that would require us to update our estimates, assumptions and judgments or revise the carrying value of our assets or liabilities. Because of the uncertainty of factors surrounding the estimates or judgments used in the preparation of the financial statements, actual results may materially vary from these estimates, and any such differences may be material to our financial statements. Revenue from sales of products is recognized at the point where the customer obtains control of the goods and we satisfy our performance obligation, which generally is at the time we ship the product to the customer. Provisions for chargebacks, rebates, discounts, and returns are established in the same period the related sales are recognized. Significant judgments must be made in determining the transaction price for our sales of products related to anticipated rebates, discounts and returns. Refer below for further details. |
Reclassifications | ReclassificationsCertain reclassifications have been made to prior year amounts to conform with the current year presentation in certain notes to these consolidated financial statements. |
Cash and Cash Equivalents | Cash and Cash Equivalents The Company considers cash and cash equivalents to be highly liquid investments with an original maturity of three months or less from the date of purchase. All cash and cash equivalents are held in United States financial institutions. The carrying amount of cash and cash equivalents a pproximates its fair value due to its short-term nature. We, at times, maintain balances with financial institutions in excess of the Federal Deposit Insurance Corporation limit. |
Fair Value Measurements | Fair Value Measurements U.S. GAAP establishes a framework for measuring fair value under generally accepted accounting principles and enhances disclosures about fair value measurements. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. The standard describes the following fair value hierarchy based on three levels of inputs, of which the first two are considered observable and the last unobservable, that may be used to measure fair value: • Level 1: Quoted prices in active markets for identical assets or liabilities. • Level 2: Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. • Level 3: Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. The fair value of interest-bearing cash, cash equivalents, accounts receivable and accounts payable approximate fair value due to their life being short term in nature, and are classified as Level 1 for all periods presented. The Company recognizes transfers between levels within the fair value hierarchy, if any, at the end of each quarter. There were no transfers in or out of Level 1, Level 2 or Level 3 during the years ended December 31, 2022 and 2021, respectively. Our investment in Enalare Therapeutics Inc., ("Enalare"), acquisition right and forward liability were classified as Level 3. We analyzed and assessed the contractual obligation to invest another $12.5 million within six months from August 2022, along with the purchase option included within the Securities Purchase Agreement (“SPA”). We used a probability factor to value the asset related to the acquired acquisition rights based on management's best estimate, including the probability of completion of certain development milestones. The equity stake was accounted for as non-readily determinable fair value ("non-RDFV”) investment. The equity investment, acquisition right and forward liability was reported at fair value as of December 31, 2022. Refer to N ote 11, Investment in Enalare Therapeutics Inc. for further information. Our investment in restricted shares of common stock of Syros Pharmaceuticals, Inc. ("Syros"), following the merger of Tyme Technologies, Inc. (“Tyme”) and Syros on September 16, 2022, are classified as Level 1. Refer to Note 9, License and Collaboration Agreements for further details. As of December 31, 2021, our investment in the convertible promissory note and the embedded derivative were classified as Level 3. We analyzed and assessed the embedded derivative feature contained in the convertible promissory note agreement. We used a probability factor to value the embedded derivative asset based on management's best estimate, including the principal and estimated accrued interest among other contractual terms. The convertible promissory note was accounted for as available for sale. The convertible promissory note was reported at fair value with unrealized gains and losses included in Accumulated other comprehensive income (loss). Refer to Note 14, Convertible Promissory Note for further details. Refer to Note 15. Business Acquisition for details regarding fair value measurements in connection with our acquisition of Acacia. |
Intangible Assets | Intangible Assets Finite-lived intangible assets are measured at their respective fair values on the date they were recorded at the date of subsequent adjustments of fair value and stated net of accumulated amortization. The fair values assigned to the Company's intangible assets are based on reasonable estimates and assumptions given available facts and circumstances. The Company amortizes its definite-lived intangible assets using either the straight-line or accelerated method, based on the useful life of the asset over which it is expected to be consumed utilizing expected undiscounted future cash flows. The Company reviews the recoverability of its finite-lived intangible assets and long-lived assets for indicators of impairments. Events or circumstances that may require an impairment assessment significant changes in our forecasted projections for the asset or asset group for reasons including, but not limited to, significant under-performance of a product in relation to expectations, significant changes or planned changes in our use of the assets, significant negative industry or economic trends, and new or competing products that enter the marketplace. If such indicators are present, the Company assesses the recoverability of affected assets by determining if the carrying value of such assets is less than the sum of the undiscounted future cash flows of the assets. If such assets are found to not be recoverable, the Company measures the amount of the impairment by comparing the carrying value of the assets to the fair value of the assets. The Company determined that no indicators of impairment of finite-lived intangible assets or long-lived assets existed as of December 31, 2022. |
Goodwill | GoodwillGoodwill represents the excess of purchase price over the fair value of net assets acquired in the Eagle Biologics and Acacia acquisition. Goodwill is not amortized, but is evaluated for impairment on an annual basis, in the fourth quarter, or more frequently if events or changes in circumstances indicate that the fair value of the reporting unit’s goodwill is less than it's carrying amount. The Company performed a qualitative annual test for goodwill as of October 1, 2022. During the year ended December 31, 2022, the Company concluded that |
Concentration of Major Customers and Vendors | Concentration of Major Customers and Vendors The Company is exposed to risks associated with extending credit to customers related to the sale of products. The Company does not require collateral to secure amounts due from its customers. The Company uses an expected loss methodology to calculate allowances for trade receivables. The Company's measurement of expected credit losses is based on relevant information about past events, including historical experience, current conditions, and reasonable and supportable forecasts that affect the collectability of the reported amount. The Company does not currently have a material allowance for collectible trade receivables. Further, the Company is dependent on its commercial partner to market and sell Bendeka; therefore, the Company's future revenues are highly dependent on the collaboration and distribution arrangement with Teva. Teva markets Bendeka through a license agreement with the Company. Pursuant to that license agreement, Teva pays the Company a royalty based on net sales of the product and also purchases the product from the Company. A disruption in this arrangement, caused by, among other things, a supply disruption, loss of exclusivity or the launch of a superior product would have a material adverse effect of the Company’s financial position, results of operations and cash flows. |
Inventories | InventoriesInventories are recorded at the lower of cost and net realizable value, with cost determined on a first-in first-out basis. The Company periodically reviews the composition of its inventories in order to identify obsolete, slow-moving or otherwise non-saleable items. If non-saleable items are observed and there are no alternate uses for the inventories, the Company will record a write-down to net realizable value in the period that the decline in value is first recognized. |
Property and Equipment | Property and Equipment Property and equipment are stated at cost. Depreciation is recorded over the estimated useful lives of the assets utilizing the straight-line method. Leasehold improvements are being amortized over the shorter of their useful lives or the lease term. |
Research and Development Expense | Research and Development Expense Costs for research and development are charged to expense as incurred and include; employee-related expenses including salaries, benefits, travel and stock-based compensation expense for research and development personnel; expenses incurred under agreements with contract research organizations, contract manufacturing organizations and service providers that assist in conducting clinical and preclinical studies; costs associated with preclinical activities and development activities, costs associated with regulatory operations; and depreciation expense for assets used in research and development activities. Costs for certain development activities, such as in licensing intellectual property related to new projects, clinical studies, are recognized based on an evaluation of the progress to completion of specific tasks using data such as patient enrollment, clinical site activations, or information provided to us by our vendors on their actual costs incurred. Payments for these activities are based on the terms of the individual arrangements, which may differ from the patterns of costs incurred, and are reflected in the consolidated financial statements as prepaid expenses or accrued expenses as deemed appropriate. Recoveries of previously |
Advertising and Marketing | Advertising and MarketingAdvertising and marketing costs are expensed as incurred. |
Income Taxes | Income Taxes We account for income taxes using the liability method in accordance with Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”), Topic 740 - Income Taxes (“ASC 740”). Deferred tax assets and liabilities are determined based on temporary differences between financial reporting and tax bases of assets and liabilities and are measured by applying enacted rates and laws to taxable years in which differences are expected to be recovered or settled. Further, the effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that the rate changes. A valuation allowance is required when it is “more likely than not” that all or a portion of deferred tax assets will not be realized. ASC 740 also prescribes a comprehensive model for how a company should recognize, measure, present and disclose in its financial statements uncertain tax positions that the company has taken or expects to take on a tax return, including a decision whether to file or not file a return in a particular jurisdiction. We recognize any interest and penalties accrued related to unrecognized tax benefits as income tax expense. |
Revenue Recognition | Revenue Recognition Revenue is recognized when a customer obtains control of promised goods or services, in an amount that reflects the consideration which the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of ASC 606, the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. The Company only applies the five-step model to contracts when it is probable that the entity will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of ASC 606, the Company assesses the goods or services promised within each contract and determines those that are performance obligations, and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. Sales, value add, and other taxes collected on behalf of third parties are excluded from revenue. Product revenue - The Company recognizes net revenue on sales to its commercial partners and to end users. In each instance, revenue is generally recognized when the customer obtains control of the Company’s product, which occurs at a point in time, and may be upon shipment or upon delivery based on the contractual shipping terms of a contract. Receivables from our product sales have payment terms ranging from 30 to 75 days with select extended terms to wholesalers on initial purchases of product launch quantities. Revenue is measured as the amount of consideration the Company expects to receive in exchange for transferring products or services to a customer. To the extent the transaction price includes variable consideration, the Company estimates the amount of variable consideration that should be included in the transaction price generally utilizing the expected value method to which the Company expects to be entitled. As such, revenue on sales to end users for vasopressin, PEMFEXY, Belrapzo, Ryanodex, BARHEMSYS, and BYFAVO are recorded net of chargebacks, rebates, returns, prompt pay discounts, wholesaler fees and other deductions. Our products are contracted with a limited number of oncology distributors and hospital buying groups with narrow differences in ultimate realized contract prices used to estimate our allowance for chargebacks and rebate reserves. The Company has a product returns policy on some of its products that allows the customer to return pharmaceutical products within a specified period of time both prior to and subsequent to the product’s expiration date. The Company's estimate of the provision for returns is analyzed quarterly and is based upon many factors, including historical experience of actual returns and analysis of the level of inventory in the distribution channel, if any. The Company has terms on sales of Ryanodex by which the Company does not accept returns. Variable consideration is included in the transaction price if, in the Company’s judgment, it is probable that a significant future reversal of cumulative revenue under the contract will not occur. Estimates of variable consideration are made generally using the expected value method and determination of whether to include estimated amounts in the transaction price are based largely on an assessment of the Company’s anticipated performance and all information (historical, current and forecasted) that is reasonably available. The Company believes that the estimates it has established are reasonable based upon current facts and circumstances. Applying different judgments to the same facts and circumstances could result in the estimated amounts to vary. Components of Gross-to-Net (GTN) Estimates Chargebacks : Chargebacks are discounts that occur when certain contracted customers, including group purchasing organizations (“GPOs”), public health service institutions and federal government entities purchasing via the Federal Supply Schedule, purchase from the Company's distributors. The Company's distributors purchase product from us at invoice price, then resell the product to certain contracted customers on the basis of prices negotiated between us and the providers. The difference between the distributors’ purchase price and the typically lower certain contracted customers’ purchase price is refunded to the distributors through a chargeback credit. We record estimates for these chargebacks at the time of sale as deductions from gross revenues, with corresponding adjustments to our accounts receivable reserves and allowances. The provision for chargebacks is the most significant provision in the context of the Company’s gross-to-net adjustments in the determination of net revenue. Chargebacks are estimated based on payer mix and contracted price, adjusted for current period assumptions. Commercial and Medicaid Rebates : The Company contracts with government agencies or collectively, third-party payors, so that vasopressin, PEMFEXY, Belrapzo, Ryanodex, BARHEMSYS, and BYFAVO will be eligible for purchase by, or partial or full reimbursement from, such third-party payors. The Company estimates the rebates it will provide to third-party payors and deducts these estimated amounts from total gross product revenues at the time the revenues are recognized. These reserves are recorded in the same period in which the revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability. The current liability is included in accrued expenses and other current liabilities on the consolidated balance sheets. The Company estimates the rebates that it will provide to third-party payors based upon (i) the Company’s contracts with these third-party payors, (ii) the government mandated discounts applicable to government-funded programs, (iii) a range of possible outcomes that are probability-weighted for the estimated payer mix, and (iv) information obtained from the Company’s distributors. The information that the Company also considers when establishing its rebate reserves are purchases by customers, projected annual sales for customers, actual rebates payments made, processing time lags, and for indirect rebates, the level of inventory in the distribution channel that will be subject to indirect rebates. We do not provide incentives designed to increase shipments to our customers that we believe would result in out-of-the-ordinary course of business inventory for them. The Company regularly reviews and monitors estimated or actual customer inventory information at its largest distributors for its key products to ascertain whether customer inventories are in excess of ordinary course of business levels. Product Returns : The Company's provision for product returns based on the factors noted above generally encompass a time range from 12 to 48 months after revenue is recognized. The Company’s distributors have the right to return unopened unprescribed vasopressin, PEMFEXY, Belrapzo, BARHEMSYS, and BYFAVO during certain time periods around the period beginning prior to the labeled expiration date and ending after the labeled expiration date. The Company estimates future product returns on sales of vasopressin, PEMFEXY, Belrapzo, BARHEMSYS, and BYFAVO based on: (i) data provided to the Company by its distributors (including weekly reporting of distributors’ sales and inventory held by distributors that provided the Company with visibility into the distribution channel in order to determine what quantities were sold to retail pharmacies and other providers), (ii) data provided to the Company by a third-party data provider which collects and publishes prescription data, and other third parties, (iii) historical industry information regarding return rates for similar pharmaceutical products, (iv) the estimated remaining shelf life of vasopressin, PEMFEXY, Belrapzo, BARHEMSYS, and BYFAVO previously shipped and currently being shipped to distributors and (v) contractual agreements intended to limit the amount of inventory maintained by the Company’s distributors. These reserves are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability which is included in accrued expenses and other current liabilities on the consolidated balance sheets. Wholesaler fees and other incentives : The Company generally provides invoice discounts on vasopressin, PEMFEXY, Belrapzo, Ryanodex, BARHEMSYS, and BYFAVO sales to its distributors for prompt payment and fees for distribution services, such as fees for certain data that distributors provide to the Company. The payment terms for sales to distributors generally include a 2% discount for prompt payment which is generally defined in invoice terms as a range from 15 to 45 days, while the fees for distribution services are based on contractual rates agreed with the respective distributors. Based on historical data, the Company expects its distributors to earn these discounts and fees, and deducts the full amount of these discounts and fees from its gross product revenues and accounts receivable at the time such revenues are recognized. In certain cases, the Company may record the fees as accrued expenses if the Company expects that the fees will be paid rather than deducted by the distributor. The Company recorded product sales, net as follows: Year Ended December 31, 2022 2021 2020 (in thousands) PEMFEXY $ 67,479 $ — $ — Vasopressin 63,159 — — Bendeka 12,992 11,167 15,439 Belrapzo 33,667 23,728 27,527 Ryanodex 30,164 25,271 28,268 Other 7,075 4,857 1,089 Product sales, net $ 214,536 $ 65,023 $ 72,323 The following table provides a summary roll-forward of the Company's net product revenue allowances and related reserves for the years ended December 31, 2022 and 2021, on the consolidated balance sheets (in thousands): Chargebacks Commercial Rebates Medicaid Rebates Product Returns Wholesaler Fees and Other Incentives Total Balance at December 31, 2020 $ 2,289 $ 1,772 $ 684 $ 1,666 $ 5,391 $ 11,802 Provisions / Adjustments 27,402 3,042 268 2,531 9,650 42,893 Charges processed / Payments (25,852) (2,838) (332) (2,674) (13,070) (44,766) Balance at December 31, 2021 $ 3,839 $ 1,976 $ 620 $ 1,523 $ 1,971 $ 9,929 Provisions / Adjustments 118,575 28,109 1,722 4,893 34,505 187,804 Charges processed / Payments (98,807) (9,399) (368) (365) (21,892) (130,831) Balance at December 31, 2022 $ 23,607 $ 20,686 $ 1,974 $ 6,051 $ 14,584 $ 66,902 Such net product revenue allowances and reserves are included within accounts receivable, net and accrued expenses and other current liabilities within the consolidated balance sheets. Royalty Revenue — The Company recognizes revenue from license arrangements with its commercial partners' net sales of products. Royalties are recognized as earned in accordance with contract terms when they can be reasonably estimated and collectability is reasonably assured. The Company's commercial partners are obligated to report their net product sales and the resulting royalty due to the Company within 25 days from the end of each quarter. Based on historical product sales, royalty receipts and other relevant information, the Company accrues royalty revenue each quarter and subsequently determines a true-up when it receives royalty reports from its commercial partners. Historically, these true-up adjustments have been immaterial. Our receivables from royalty revenue are due 45-days from the end of the quarter.. License and other revenue — The Company analyzes each element of its licensing agreements to determine the appropriate revenue recognition. The terms of the license agreement may include payment to us of non-refundable up-front license fees, milestone payments if specified objectives are achieved, and/or royalties on product sales. The Company recognizes revenue from upfront payments at a point in time, typically upon fulfilling the delivery of the associated intellectual property to the customer. If the contract contains a single performance obligation, the entire transaction price is allocated to the single performance obligation. Contracts that contain multiple performance obligations require an allocation of the transaction price based on the estimated relative standalone selling prices of the promised products or services underlying each performance obligation. The Company determines standalone selling prices based on the price at which the performance obligation is sold separately. If the standalone selling price is not observable through past transactions, the Company estimates the standalone selling price taking into account available information such as market conditions and internally approved pricing guidelines related to the performance obligations. The Company recognizes sales-based milestone payments as revenue upon the achievement of the cumulative sales amount specified in the contract in accordance with ASC 606-10-55-65. For those milestone payments which are contingent on the occurrence of particular future events, the Company determined that these need to be considered for inclusion in the calculation of total consideration from the contract as a component of variable consideration using the most-likely amount method. As such, the Company assesses each milestone to determine the probability and substance behind achieving each milestone. Given the inherent uncertainty of the occurrence of these future events, the Company will not recognize revenue from the milestone until there is not a high probability of a reversal of revenue, which typically occurs near or upon achievement of the event. |
Stock-Based Compensation | Stock-Based Compensation The Company utilizes stock-based compensation in the form of stock options, restricted stock units ("RSUs") and performance-based stock units ("PSUs"), each of which may be granted separately or in tandem with other awards. Compensation expense is recognized in the Consolidated Statements of operations based on the estimated fair value of the awards at grant date ratably over the requisite service period, which generally equals the vesting period of the award. The grant-date fair value of stock awards is based upon the underlying price of the stock on the date of grant. The grant-date fair value of stock option awards must be determined using an option pricing model. The Company uses the Black-Scholes option pricing formula for determining the grant-date fair value of such awards. Option pricing models require the use of estimates and assumptions as to (a) the expected term of the option, (b) the expected volatility of the price of the underlying stock and (c) the risk-free interest rate for the expected term of the option. The Company may also grant performance-based stock awards to employees from time-to-time in form of market condition or performance condition. The grant-date fair value of awards that vest based on achievement of certain market condition are determined using a Monte Carlo simulation technique. The grant-date fair value of awards that vest based on achievement of certain performance condition are determined using the accelerated attribution method once it is probable that the performance condition will be achieved. |
Earnings Per Share | Earnings Per ShareBasic earnings per common share is computed using the weighted average number of shares outstanding during the period. Diluted earnings per share is computed in a manner similar to the basic earnings per share, except that the weighted-average number of shares outstanding is increased to include all common shares, including those with the potential to be issued by virtue of options. Diluted earnings per share contemplate a complete conversion to common shares of all convertible instruments only if they are dilutive in nature with regards to earnings per share, as calculated under the treasury method. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Policies [Abstract] | |
Schedule of financial assets and liabilities measured and recognized at fair value | The following tables present the Company’s hierarchy for its assets measured at fair value as of December 31, 2022 and 2021: December 31, 2022 Total Level 1 Level 2 Level 3 Assets: Money market funds $ 47,567 $ 47,567 $ — $ — Investment in Syros Pharmaceuticals, Inc. ("Syros") 1,573 1,573 — — Investment in Enalare Therapeutics, Inc. 8,438 — — 8,438 Acquisition rights of Enalare Therapeutics, Inc. 8,125 — — 8,125 Liability: Forward Liability 4,063 — — 4,063 December 31, 2021 Total Level 1 Level 2 Level 3 Assets: Money market funds $ 57,357 $ 57,357 $ — $ — Convertible promissory note 4,021 — — 4,021 Embedded derivative asset in convertible promissory note 962 — — 962 Investment in Syros 6,030 6,030 |
Schedule of revenues and accounts receivables by major customers | The total revenues and accounts receivables broken down by major customers as a percentage of the total are as follows: Year Ended December 31, 2022 2021 2020 Total revenues Teva - See Revenue Recognition 33 % 66 % 67 % Customer A 19 % 7 % 10 % Customer B 12 % 9 % 5 % Customer C 12 % 4 % 2 % Customer D 9 % 8 % 9 % Other 15 % 6 % 7 % 100 % 100 % 100 % December 31, 2022 2021 Accounts receivable Teva - See Revenue Recognition 31 % 63 % Customer A 1 % 13 % Customer B 57 % 13 % Customer C 5 % 2 % Customer D 2 % 2 % Other 4 % 7 % 100 % 100 % |
Schedule of revenue from external customers by products and services | The Company recorded product sales, net as follows: Year Ended December 31, 2022 2021 2020 (in thousands) PEMFEXY $ 67,479 $ — $ — Vasopressin 63,159 — — Bendeka 12,992 11,167 15,439 Belrapzo 33,667 23,728 27,527 Ryanodex 30,164 25,271 28,268 Other 7,075 4,857 1,089 Product sales, net $ 214,536 $ 65,023 $ 72,323 |
Schedule of sales allowances and related accruals | The following table provides a summary roll-forward of the Company's net product revenue allowances and related reserves for the years ended December 31, 2022 and 2021, on the consolidated balance sheets (in thousands): Chargebacks Commercial Rebates Medicaid Rebates Product Returns Wholesaler Fees and Other Incentives Total Balance at December 31, 2020 $ 2,289 $ 1,772 $ 684 $ 1,666 $ 5,391 $ 11,802 Provisions / Adjustments 27,402 3,042 268 2,531 9,650 42,893 Charges processed / Payments (25,852) (2,838) (332) (2,674) (13,070) (44,766) Balance at December 31, 2021 $ 3,839 $ 1,976 $ 620 $ 1,523 $ 1,971 $ 9,929 Provisions / Adjustments 118,575 28,109 1,722 4,893 34,505 187,804 Charges processed / Payments (98,807) (9,399) (368) (365) (21,892) (130,831) Balance at December 31, 2022 $ 23,607 $ 20,686 $ 1,974 $ 6,051 $ 14,584 $ 66,902 |
Schedule of dilutive and anti-dilutive common shares equivalents outstanding | The anti-dilutive common shares equivalents outstanding at December 31, 2022, 2021, and 2020 were as follows: Year Ended December 31, 2022 2021 2020 Options 2,273,590 2,336,586 2,767,501 Restricted stock units 235,860 98,416 207,177 Total 2,509,450 2,435,002 2,974,678 |
Schedule of computation for basic and diluted net (loss) earnings per share | The following table sets forth the computation for basic and diluted net income (loss) per share for December 31, 2022, 2021, and 2020: Year Ended December 31, 2022 2021 2020 Numerator Numerator for basic and diluted earnings per share-net income (loss) $ 35,642 (8,627) $ 11,989 Denominator Basic weighted average common shares outstanding 12,933,896 13,051,095 13,481,525 Dilutive effect of stock options 131,598 — 289,868 Diluted weighted average common shares outstanding 13,065,494 13,051,095 13,771,393 Basic net income (loss) per share Basic net income (loss) per share $ 2.76 $ (0.66) $ 0.89 Diluted net income (loss) per share Diluted net income (loss) per share $ 2.73 $ (0.66) $ 0.87 |
Inventories (Tables)
Inventories (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Inventory Disclosure [Abstract] | |
Schedule of inventory | The Company's inventory balance consists of the following: December 31, 2022 2021 Raw materials $ 12,348 $ 7,317 Work-in-process 14,064 9,666 Finished goods 21,382 4,925 $ 47,794 $ 21,908 |
Property and Equipment, net (Ta
Property and Equipment, net (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Property, Plant and Equipment [Abstract] | |
Schedule of property and equipment, net | Property and equipment consists of the following: December 31, Estimated Useful Life (years) 2022 2021 Furniture and fixtures $ 1,525 $ 1,525 7 Office equipment 1,077 1,077 3 Equipment 4,012 3,834 7 Leasehold improvements 1,155 1,155 2 7,769 7,591 Less accumulated depreciation (6,601) (5,955) Property and equipment, net $ 1,168 $ 1,636 |
Balance Sheet Accounts (Tables)
Balance Sheet Accounts (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Balance Sheet Related Disclosures [Abstract] | |
Schedule of prepaid and other current assets | Prepaid and other current assets consist of the following: December 31, 2022 2021 Advances to commercial manufacturers $ 5,464 $ 2,354 Prepaid FDA user fee and advances to CROs 3,022 1,108 Prepaid insurance 258 196 Prepaid income taxes 90 1,173 Prepaid R&D 106 — Convertible promissory note, net — 5,312 Pass-through receivables 1,001 347 All other 3,259 1,400 Total Prepaid expenses and other current assets $ 13,200 $ 11,890 |
Schedule of accrued expenses and other liabilities | Accrued expenses and other liabilities consist of the following: December 31, 2022 2021 Royalties payable to commercial partners $ 7,205 $ 5,085 Accrued research & development 1,549 4,100 Accrued professional fees 5,541 2,013 Accrued salary and other compensation 5,293 8,466 Accrued product sales reserves 33,000 4,390 Current portion of lease liability 1,534 1,309 Inventory received but not invoiced 6,779 6,177 Income taxes payable 5,182 — Forward liability related to Enalare 4,063 — PEMFEXY royalty buy-down payable 15,000 — All other 698 798 Total Accrued expenses and other liabilities $ 85,844 $ 32,338 |
Schedule of lease related disclosures | The table below summarizes the Company's total lease costs included in the consolidated financial statements, as well as other required quantitative disclosures (in thousands): As of December 31, 2022 2021 Operating lease cost $ 1,507 $ 1,407 Total lease cost $ 1,507 $ 1,407 Other information: Cash paid for amounts included in the measurement of lease liabilities Operating cash flows for operating leases $ 1,507 $ 1,407 Right-of-use assets obtained in exchange for new operating lease liabilities $ — $ 270 Weighted-average remaining lease term - operating leases 2.1 years 3.1 years Weighted-average discount rate - operating leases 6.0 % 6.0 % |
Schedule of future minimum lease payments | Balance Sheet Classification as of December 31, 2022 Current lease liabilities (included with Accrued expenses and other liabilities) $ 1,534 Long-term lease liabilities (included with Other long-term liabilities) 1,508 Total lease liabilities $ 3,042 |
Debt (Tables)
Debt (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Debt Disclosure [Abstract] | |
Schedule of debt maturities | Debt Maturities As of December 31, 2022 2023 $ 6,250 2024 10,000 2025 47,500 Total $ 63,750 |
Common Stock and Stock-Based _2
Common Stock and Stock-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
Schedule of class of treasury stock | We repurchased the following shares of common stock with cash resources: Year Ended December 31, 2022 2021 2020 Shares of common stock repurchased 441,108 429,446 774,489 Cash paid for r epurchases of common stock $ 18,004 $ 21,213 $ 34,999 |
Schedule of fair value of stock options | The fair value of stock options granted to employees, directors, and consultants is estimated using the following assumptions: Year Ended December 31, 2022 2021 2020 Risk-free interest rate 1.47% - 4.3% 0.51% - 1.26% 0.37% - 1.65% Volatility 45.59% - 51.31% 52.87% - 60.02% 54.89% Expected term (in years) 5.50 - 6.08 years 5.50 - 6.08 years 5.50 - 6.08 years Expected dividend yield 0.0% 0.0% 0.0% |
Share-based compensation arrangement by share-based payment award | The following table summarizes information about stock option activity related to the 2014 Plan: Number of Weighted Non- Exercisable Outstanding at December 31, 2020 3,331,890 $ 59.20 1,028,142 2,303,748 Granted 114,000 $ 46.74 Exercised (122,847) $ 27.64 Forfeited or expired (508,165) $ 62.00 Outstanding at December 31, 2021 2,814,878 $ 58.51 472,916 2,341,962 Granted 139,700 $ 44.15 Exercised (91,255) $ 25.74 Forfeited or expired (437,490) $ 62.89 Outstanding at December 31, 2022 2,425,833 $ 57.51 310,622 2,115,211 |
Schedule of restricted stock unit activity | The following table summarizes information about RSU activity related to the 2014 Plan: Number of Weighted Non-vested at December 31, 2020 328,396 $ 53.09 Granted 106,600 $ 48.55 Vested (95,523) $ 52.26 Forfeited (76,167) $ 52.29 Non-vested at December 31, 2021 263,306 $ 51.77 Granted 148,000 $ 47.75 Vested (103,148) $ 51.39 Forfeited (38,995) $ 50.57 Non-vested at December 31, 2022 269,163 $ 49.88 |
Schedule of phantom share unit activity | The following table summarizes information about PSU activity related to the 2014 Plan: Number of Weighted Non-vested at December 31, 2020 97,750 $ 90.19 Granted 159,000 $ 62.94 Vested — $ — Forfeited (119,450) $ 84.90 Non-vested at December 31, 2021 137,300 $ 63.24 Granted 228,200 $ 63.93 Vested — $ — Forfeited (46,400) $ 59.27 Non-vested at December 31, 2022 319,100 $ 63.96 |
Share-based payment arrangement, cost by plan | The Company recognized stock-based compensation in its consolidated statements of operations for the year ended December 31, 2022, 2021, and 2020 as follows: Year Ended December 31, 2022 2021 2020 Stock options $ 6,714 $ 11,521 $ 17,694 PSUs 4,665 2,729 1,635 RSUs 5,072 5,305 5,427 Stock-based compensation expense $ 16,451 $ 19,555 $ 24,756 Selling, general and administrative $ 14,001 $ 16,873 $ 22,074 Research and development 2,450 2,682 2,682 Stock-based compensation expense $ 16,451 $ 19,555 $ 24,756 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | |
Schedule of components of income tax provision | The components of our provision from income taxes is as follows: Year Ended December 31, 2022 2021 2020 Current: Federal $ 30,933 $ 6,912 $ 10,140 State 3,181 785 2,059 $ 34,114 $ 7,697 $ 12,199 Deferred: Federal (7,607) (3,030) (1,227) State (740) (588) (284) Foreign 24 — — $ (8,323) $ (3,618) $ (1,511) Provision for income taxes $ 25,791 $ 4,079 $ 10,688 |
Schedule of effective income tax rate reconciliation | The reconciliation of the statutory U.S. Federal income tax rate to the Company's effective income tax rate is as follows: Year Ended December 31, 2022 2021 2020 U.S. Federal statutory tax rate 21 % 21 % 21 % State income taxes, net of federal benefit 3 % (1) % 6 % Tax effect on stock option exercises, net of forfeitures 2 % (44) % 4 % R&D tax credits and Orphan Drug credits (1) % 31 % (2) % Limitation on executive compensation 3 % (60) % 9 % Change in valuation allowance 13 % (40) % 9 % Transaction costs 3 % — — Foreign rate differential (2) % 4 % (1) % Other — (1) % 1 % Effective tax rate 42 % (90) % 47 % |
Schedule of deferred tax assets and liabilities | Significant components of the Company's deferred tax assets were as follows: December 31, 2022 2021 Deferred tax assets Net operating loss carryforward $ 46,996 $ 1,563 Stock based compensation 9,875 10,405 Other asset - equity investment with readily determined fair value 4,197 3,190 Inventories 3,405 2,123 Employee-related expenses 205 1,240 Intangible assets 4,559 4,207 Right-of-use liability 688 962 R&D tax credit carryforwards 471 329 Capitalized R&D 7,579 — Other 3,659 1,489 Total deferred tax assets 81,634 25,508 Deferred tax liabilities Installment sale - Malta 484 485 Prepaid expenses 59 45 Fixed assets 255 300 Lease liability 648 921 Intangible assets 18,530 — Inventory 2,981 — Other 247 — Total deferred tax liabilities 23,204 1,751 Valuation allowance (35,101) (4,959) Net deferred tax assets $ 23,329 $ 18,798 |
Commitments (Tables)
Commitments (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of operating lease obligations and purchase obligations | Our future material contractual obligations include the following: Obligation Total 2023 2024 2025 Beyond Operating leases (1) $ 3,207 $ 1,672 $ 1,122 $ 413 $ — Credit facility and Term loans (2) 63,750 6,250 10,000 47,500 — Investment in Enalare (3) 12,500 12,500 — — — Purchase obligations (4) 87,501 87,501 — — — Total obligations $ 166,958 $ 107,923 $ 11,122 $ 47,913 $ — (1) We lease our corporate office location. The term of our existing lease expires on June 30, 2025. We also lease our lab space under a lease agreement through April 2024, office space located in Indianapolis, Indiana through November 2023, and an office space in Palm Beach Gardens, Florida, through October 31, 2024. Rental expense was $1,507, $1,407, and $1,323, for the years ended December 31, 2022, 2021, and 2020, respectively. The remaining future lease payments under the operating leases, exclusive of any renewal option periods, are $3,207 as of December 31, 2022, payable monthly. December 31, 2022 Total operating lease payments $ 3,207 Less: imputed interest (165) Total lease liabilities $ 3,042 (2) Refer to Note 6, “Debt” for further information regarding our Credit Agreement and Term Loans. (3) We invested $12.5 million in Enalare at the time of entering the agreement in August 2022, and we are contractually obligated to invest another $12.5 million six months after August 2022. Refer to No te 11, Investment in Enalare Therapeutics Inc. for further details. (4) As of December 31, 2022, the Company has purchase obligations in the amount of $87.5 million which represents the contractual commitments under contract manufacturing and supply agreements with suppliers. The obligation under the supply agreement is primarily for finished product, inventory, and research and development. |
Investment in Enalare Therape_2
Investment in Enalare Therapeutics Inc. (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Equity Method Investments and Joint Ventures [Abstract] | |
Schedule of equity method investments | Summarized financial information of our investment and equity ownership in Enalare for the year ended December 31, 2022 is presented below: Beginning balance as of January 1, 2022 Additions during period Adjustments Ending balance as of December 31, 2022 Non-RDFV Investment $ — $ 8,438 $ — $ 8,438 Acquisition Rights (Other assets) — 8,125 — 8,125 Forward Liability (Accrued expenses and other liabilities) — (4,063) — (4,063) Total, net $ — $ 12,500 $ — $ 12,500 |
Intangible Assets, Net (Tables)
Intangible Assets, Net (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Schedule of intangible asset | The gross carrying amounts and net book value of our intangible assets are as follows: December 31, 2022 Useful Life (In Years) Gross Carrying Amount Accumulated Amortization Accumulated Impairment Charges Net Book Value BARHEMSYS intangible (1) 9 $ 70,319 $ (4,462) $ — $ 65,857 BYFAVO intangible (1) 9 33,714 (1,989) — 31,725 Ryanodex intangible (2) 9 15,000 (7,402) — 7,598 PEMFEXY intangible (3) 2 15,000 (1,888) — 13,112 Vasopressin Milestone (4) 1 750 (715) — 35 Total $ 134,783 $ (16,456) $ — $ 118,327 December 31, 2021 Useful Life (In Years) Gross Carrying Amount Accumulated Amortization Accumulated Impairment Charge Net Book Value Ryanodex intangible (2) 9 $ 15,000 $ (5,079) $ — $ 9,921 Developed technology 5 8,100 (8,100) — — Vasopressin Milestone (4) 1 750 — — 750 Total $ 23,850 $ (13,179) $ — $ 10,671 (1) Represents intangible assets acquired in the Acacia Pharma acquisition as detailed in Note 15. (2) Represents a one-time payment made to reduce the royalties payable to a third party on Ryanodex net sales. (3) Represents a one-time payment made to reduce the royalties payable to a third party on PEMFEXY net sales. |
Schedule of future amortization expense of finite-lived intangible assets | Based on definite-lived intangible assets recorded as of December 31, 2022, and assuming that the underlying assets will not be impaired and that the Company will not change the expected lives of the assets, future amortization expenses are estimated as follows: Estimated Amortization Expense Year Ending December 31, 2023 21,916 2024 19,770 2025 13,908 2026 11,606 2027 11,606 Thereafter 39,521 Total estimated amortization expense $ 118,327 |
Convertible Promissory Note (Ta
Convertible Promissory Note (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Investments, Debt and Equity Securities [Abstract] | |
Schedule of debt Securities, Available-for-sale | The following table summarizes the amounts recorded and activity during the year ended December 31, 2022; December 31, 2021 Fair Value Adjustments to the note Accretion of Discount Estimated Credit Loss Interest Income Fair Value Adjustment to Embedded Derivative December 31, 2022 Fair value of the note $ 4,906 $ (4,906) $ — $ — $ — $ — $ — Discount on the note (127) — 127 — — — — Estimated Credit Loss (758) — — 758 — — — Convertible Promissory Note, net $ 4,021 $ (4,906) $ 127 $ 758 $ — $ — $ — Embedded Derivative $ 962 $ — $ — $ — $ — $ (962) $ — Interest Receivable $ 329 $ — $ — $ (329) $ — $ — $ — Total in Other Current Assets $ 5,312 $ (4,906) $ 127 $ 429 $ — $ (962) $ — Initial Fair Value Adjustments to the note Accretion of Discount Estimated Credit Loss Interest Income Fair Value Adjustment to Embedded Derivative December 31, 2021 Fair value of the note $ 5,000 $ (94) $ — $ — $ — $ — $ 4,906 Discount on the note (276) — 149 — — — (127) Estimated Credit Loss — — — (758) — — (758) Convertible Promissory Note, net $ 4,724 $ (94) $ 149 $ (758) $ — $ — $ 4,021 Embedded Derivative $ 276 $ — $ — $ — $ — $ 686 $ 962 Interest Receivable $ — $ — $ — $ — $ 329 $ — $ 329 Total in Other Current Assets $ 5,000 $ (94) $ 149 $ (758) $ 329 $ 686 $ 5,312 |
Business Acquisition (Tables)
Business Acquisition (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Business Combination and Asset Acquisition [Abstract] | |
Schedule of business acquisitions, by acquisition | The acquisition-date fair value of the consideration totaled $100.4 million, summariz ed as follows (in thousands): Fair Value of Consideration Cash consideration $ 76,708 Fair value of Eagle common stock issued 23,645 $ 100,353 |
Schedule of recognized identified assets acquired and liabilities assumed | The following table presents the allocation of the purchase price to the estimated fair values of the assets acquired and liabilities assumed as of the acquisition date (in thousands): Preliminary Purchase Price Allocation as of acquisition date Measurement Period Adjustments Purchase Price Allocation Cash $ 2,556 $ — $ 2,556 Net working capital, excluding cash (2,158) — (2,158) Inventory 26,942 (9,394) 17,548 Intangible assets 104,000 4,000 108,000 Debt (28,503) 1,844 (26,659) Deferred tax liability, net (4,536) 311 (4,225) Fair value of net assets acquired 98,301 (3,239) 95,062 Goodwill 3,315 1,976 5,291 $ 101,616 $ (1,263) $ 100,353 |
Schedule of business acquisition, pro forma information | The following table provides unaudited pro forma financial information for the years ended December 31, 2022 and 2021 as if the acquisition of Acacia Pharma had occurred as of January 1, 2021: Year Ended 2022 2021 Total revenue $ 317,792 $ 172,709 Net income (loss) $ 19,189 $ (92,886) |
Organization and Business (Deta
Organization and Business (Details) | 3 Months Ended | 12 Months Ended | 77 Months Ended | ||||
Nov. 01, 2022 USD ($) | Sep. 30, 2022 USD ($) | Dec. 31, 2022 USD ($) segment product shares | Dec. 31, 2021 USD ($) shares | Dec. 31, 2020 USD ($) shares | Dec. 31, 2022 USD ($) shares | Jan. 07, 2020 USD ($) | |
Subsidiary, Sale of Stock [Line Items] | |||||||
Number of products commercially launched | product | 6 | ||||||
Number of reportable segments | segment | 1 | ||||||
Shares of common stock repurchased (in shares) | shares | 441,108 | 429,446 | 774,489 | ||||
Cash paid for repurchases of common stock | $ 18,004,000 | $ 21,213,000 | $ 34,999,000 | ||||
Installment payment amount | $ 6,250,000 | ||||||
Tyme | Collaborative Arrangement, Transaction with Party to Collaborative Arrangement | |||||||
Subsidiary, Sale of Stock [Line Items] | |||||||
Co-promotion agreement, percentage of promotional sales effort responsible for | 25% | ||||||
Co-promotion agreement, percentage of net revenue receivable | 15% | ||||||
Co-promotion agreement, percentage of net revenue receivable due to collaborator | 85% | ||||||
Co-promotion agreement, right to repurchase, amount | $ 200,000,000 | ||||||
Revolving Credit Facility | |||||||
Subsidiary, Sale of Stock [Line Items] | |||||||
Proceeds from line of credit | $ 15,000,000 | ||||||
Third Amended and Restated Credit Agreement | |||||||
Subsidiary, Sale of Stock [Line Items] | |||||||
Proceeds from line of credit | $ 35,400,000 | ||||||
Third Amended and Restated Credit Agreement | Revolving Credit Facility | |||||||
Subsidiary, Sale of Stock [Line Items] | |||||||
Long-term line of credit | 15,000,000 | ||||||
Third Amended and Restated Credit Agreement | Line of Credit | |||||||
Subsidiary, Sale of Stock [Line Items] | |||||||
Maximum borrowing capacity | $ 50,000,000 | ||||||
Third Amended and Restated Credit Agreement | Line of Credit | Minimum | |||||||
Subsidiary, Sale of Stock [Line Items] | |||||||
Line of credit facility, commitment fee (as a percent) | 0.38% | ||||||
Third Amended and Restated Credit Agreement | Line of Credit | Minimum | Secured Overnight Financing Rate (SOFR) | |||||||
Subsidiary, Sale of Stock [Line Items] | |||||||
Variable interest rate spread (as a percent) | 2.50% | ||||||
Third Amended and Restated Credit Agreement | Line of Credit | Minimum | New York Federal Reserve Bank (NYFRB) | |||||||
Subsidiary, Sale of Stock [Line Items] | |||||||
Variable interest rate spread (as a percent) | 1.50% | ||||||
Third Amended and Restated Credit Agreement | Line of Credit | Maximum | |||||||
Subsidiary, Sale of Stock [Line Items] | |||||||
Line of credit facility, commitment fee (as a percent) | 0.48% | ||||||
Third Amended and Restated Credit Agreement | Line of Credit | Maximum | Secured Overnight Financing Rate (SOFR) | |||||||
Subsidiary, Sale of Stock [Line Items] | |||||||
Variable interest rate spread (as a percent) | 3.25% | ||||||
Third Amended and Restated Credit Agreement | Line of Credit | Maximum | New York Federal Reserve Bank (NYFRB) | |||||||
Subsidiary, Sale of Stock [Line Items] | |||||||
Variable interest rate spread (as a percent) | 2.25% | ||||||
Third Amended and Restated Credit Agreement | Line of Credit | Revolving Credit Facility | |||||||
Subsidiary, Sale of Stock [Line Items] | |||||||
Maximum borrowing capacity | $ 100,000,000 | ||||||
Long-term line of credit | 15,000,000 | ||||||
Third Amended and Restated Credit Agreement | 2022 Term Loan | |||||||
Subsidiary, Sale of Stock [Line Items] | |||||||
Long-term line of credit | $ 50,000,000 | ||||||
Accelerated Share Repurchase | |||||||
Subsidiary, Sale of Stock [Line Items] | |||||||
Shares of common stock repurchased (in shares) | shares | 4,552,730 | ||||||
Cash paid for repurchases of common stock | $ 246,100,000 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Schedule of Financial Assets and Liabilities Measured and Recognized at Fair Value (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Assets: | ||
Money market funds | $ 47,567 | $ 57,357 |
Acquisition rights of Enalare Therapeutics, Inc. | 8,125 | |
Convertible promissory note | 4,021 | |
Embedded derivative asset in convertible promissory note | 962 | |
Liability: | ||
Forward Liability | 4,063 | |
Investment in Syros Pharmaceuticals, Inc. ("Syros") | ||
Assets: | ||
Investments | 1,573 | 6,030 |
Investment in Enalare Therapeutics, Inc. | ||
Assets: | ||
Investments | 8,438 | 0 |
Acquisition rights of Enalare Therapeutics, Inc. | 8,125 | 0 |
Liability: | ||
Forward Liability | 4,063 | 0 |
Level 1 | ||
Assets: | ||
Money market funds | 47,567 | 57,357 |
Acquisition rights of Enalare Therapeutics, Inc. | 0 | |
Convertible promissory note | 0 | |
Embedded derivative asset in convertible promissory note | 0 | |
Liability: | ||
Forward Liability | 0 | |
Level 1 | Investment in Syros Pharmaceuticals, Inc. ("Syros") | ||
Assets: | ||
Investments | 1,573 | 6,030 |
Level 1 | Investment in Enalare Therapeutics, Inc. | ||
Assets: | ||
Investments | 0 | |
Level 2 | ||
Assets: | ||
Money market funds | 0 | 0 |
Acquisition rights of Enalare Therapeutics, Inc. | 0 | |
Convertible promissory note | 0 | |
Embedded derivative asset in convertible promissory note | 0 | |
Liability: | ||
Forward Liability | 0 | |
Level 2 | Investment in Syros Pharmaceuticals, Inc. ("Syros") | ||
Assets: | ||
Investments | 0 | |
Level 2 | Investment in Enalare Therapeutics, Inc. | ||
Assets: | ||
Investments | 0 | |
Level 3 | ||
Assets: | ||
Money market funds | 0 | 0 |
Acquisition rights of Enalare Therapeutics, Inc. | 8,125 | |
Convertible promissory note | 4,021 | |
Embedded derivative asset in convertible promissory note | 962 | |
Liability: | ||
Forward Liability | 4,063 | |
Level 3 | Investment in Syros Pharmaceuticals, Inc. ("Syros") | ||
Assets: | ||
Investments | 0 | |
Level 3 | Investment in Enalare Therapeutics, Inc. | ||
Assets: | ||
Investments | $ 8,438 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Narrative (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Disaggregation of Revenue [Line Items] | |||
Investment in contractual obligation within another six months | $ 12,500 | ||
Advertising and marketing costs | $ 8,500 | $ 2,600 | $ 2,700 |
Wholesaler discount (as a percent) | 2% | ||
Minimum | |||
Disaggregation of Revenue [Line Items] | |||
Wholesaler discount, prompt payment term (in days) | 15 days | ||
Maximum | |||
Disaggregation of Revenue [Line Items] | |||
Wholesaler discount, prompt payment term (in days) | 45 days | ||
Product sales, net | Minimum | |||
Disaggregation of Revenue [Line Items] | |||
Payment terms for receivables (in days) | 30 days | ||
Term for sales returns (in months) | 12 months | ||
Product sales, net | Maximum | |||
Disaggregation of Revenue [Line Items] | |||
Payment terms for receivables (in days) | 75 days | ||
Term for sales returns (in months) | 48 months | ||
Royalty revenue | |||
Disaggregation of Revenue [Line Items] | |||
Payment terms for receivables (in days) | 45 days | ||
Reporting term from end of each quarter for commercial partners (in days) | 25 days |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Revenue and Accounts Receivable By Major Customer (Details) - Customer Concentration Risk | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Total revenues | |||
Concentration Risk [Line Items] | |||
Percentage of concentration | 100% | 100% | 100% |
Total revenues | Teva | |||
Concentration Risk [Line Items] | |||
Percentage of concentration | 33% | 66% | 67% |
Total revenues | Customer A | |||
Concentration Risk [Line Items] | |||
Percentage of concentration | 19% | 7% | 10% |
Total revenues | Customer B | |||
Concentration Risk [Line Items] | |||
Percentage of concentration | 12% | 9% | 5% |
Total revenues | Customer C | |||
Concentration Risk [Line Items] | |||
Percentage of concentration | 12% | 4% | 2% |
Total revenues | Customer D | |||
Concentration Risk [Line Items] | |||
Percentage of concentration | 9% | 8% | 9% |
Total revenues | Other | |||
Concentration Risk [Line Items] | |||
Percentage of concentration | 15% | 6% | 7% |
Accounts receivable | |||
Concentration Risk [Line Items] | |||
Percentage of concentration | 100% | 100% | |
Accounts receivable | Teva | |||
Concentration Risk [Line Items] | |||
Percentage of concentration | 31% | 63% | |
Accounts receivable | Customer A | |||
Concentration Risk [Line Items] | |||
Percentage of concentration | 1% | 13% | |
Accounts receivable | Customer B | |||
Concentration Risk [Line Items] | |||
Percentage of concentration | 57% | 13% | |
Accounts receivable | Customer C | |||
Concentration Risk [Line Items] | |||
Percentage of concentration | 5% | 2% | |
Accounts receivable | Customer D | |||
Concentration Risk [Line Items] | |||
Percentage of concentration | 2% | 2% | |
Accounts receivable | Other | |||
Concentration Risk [Line Items] | |||
Percentage of concentration | 4% | 7% |
Summary of Significant Accoun_7
Summary of Significant Accounting Policies - Schedule of Product Sales (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Product Information [Line Items] | |||
Total revenue | $ 316,610 | $ 171,546 | $ 187,802 |
PEMFEXY | |||
Product Information [Line Items] | |||
Total revenue | 67,479 | 0 | 0 |
Vasopressin | |||
Product Information [Line Items] | |||
Total revenue | 63,159 | 0 | 0 |
Bendeka | |||
Product Information [Line Items] | |||
Total revenue | 12,992 | 11,167 | 15,439 |
Belrapzo | |||
Product Information [Line Items] | |||
Total revenue | 33,667 | 23,728 | 27,527 |
Ryanodex | |||
Product Information [Line Items] | |||
Total revenue | 30,164 | 25,271 | 28,268 |
Other | |||
Product Information [Line Items] | |||
Total revenue | 7,075 | 4,857 | 1,089 |
Product sales, net | |||
Product Information [Line Items] | |||
Total revenue | $ 214,536 | $ 65,023 | $ 72,323 |
Summary of Significant Accoun_8
Summary of Significant Accounting Policies - Summary of Sales Allowances and Related Accruals (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Sales Revenue, Deductions [Roll Forward] | ||
Beginning balance | $ 9,929 | $ 11,802 |
Provisions / Adjustments | 187,804 | 42,893 |
Charges processed / Payments | (130,831) | (44,766) |
Ending balance | 66,902 | 9,929 |
Chargebacks | ||
Sales Revenue, Deductions [Roll Forward] | ||
Beginning balance | 3,839 | 2,289 |
Provisions / Adjustments | 118,575 | 27,402 |
Charges processed / Payments | (98,807) | (25,852) |
Ending balance | 23,607 | 3,839 |
Commercial Rebates | ||
Sales Revenue, Deductions [Roll Forward] | ||
Beginning balance | 1,976 | 1,772 |
Provisions / Adjustments | 28,109 | 3,042 |
Charges processed / Payments | (9,399) | (2,838) |
Ending balance | 20,686 | 1,976 |
Medicaid Rebates | ||
Sales Revenue, Deductions [Roll Forward] | ||
Beginning balance | 620 | 684 |
Provisions / Adjustments | 1,722 | 268 |
Charges processed / Payments | (368) | (332) |
Ending balance | 1,974 | 620 |
Product Returns | ||
Sales Revenue, Deductions [Roll Forward] | ||
Beginning balance | 1,523 | 1,666 |
Provisions / Adjustments | 4,893 | 2,531 |
Charges processed / Payments | (365) | (2,674) |
Ending balance | 6,051 | 1,523 |
Wholesaler Fees and Other Incentives | ||
Sales Revenue, Deductions [Roll Forward] | ||
Beginning balance | 1,971 | 5,391 |
Provisions / Adjustments | 34,505 | 9,650 |
Charges processed / Payments | (21,892) | (13,070) |
Ending balance | $ 14,584 | $ 1,971 |
Summary of Significant Accoun_9
Summary of Significant Accounting Policies - Common Shares Equivalents Outstanding (Details) - shares | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Anti-dilutive common shares equivalents outstanding (in shares) | 2,509,450 | 2,435,002 | 2,974,678 |
Options | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Anti-dilutive common shares equivalents outstanding (in shares) | 2,273,590 | 2,336,586 | 2,767,501 |
Restricted stock units | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Anti-dilutive common shares equivalents outstanding (in shares) | 235,860 | 98,416 | 207,177 |
Summary of Significant Accou_10
Summary of Significant Accounting Policies - Earnings Per Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Numerator | |||
Numerator for basic earnings per share-net (loss) income | $ 35,642 | $ (8,627) | |
Numerator for diluted earnings per share-net (loss) income | $ 35,642 | $ (8,627) | |
Denominator | |||
Basic weighted average common shares outstanding (in shares) | 12,933,896 | 13,051,095 | 13,481,525 |
Dilutive effect of stock options (in shares) | 131,598 | 0 | 289,868 |
Diluted weighted average common shares outstanding (in shares) | 13,065,494 | 13,051,095 | 13,771,393 |
Basic net income (loss) per share | |||
Basic net (loss) income per share (in dollars per share) | $ 2.76 | $ (0.66) | $ 0.89 |
Diluted net income (loss) per share | |||
Diluted net (loss) income per share (in dollars per share) | $ 2.73 | $ (0.66) | $ 0.87 |
Inventories (Details)
Inventories (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 12,348 | $ 7,317 |
Work-in-process | 14,064 | 9,666 |
Finished goods | 21,382 | 4,925 |
Inventories | $ 47,794 | $ 21,908 |
Property and Equipment, net (De
Property and Equipment, net (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Property, Plant and Equipment [Line Items] | ||
Property and equipment | $ 7,769 | $ 7,591 |
Less accumulated depreciation | (6,601) | (5,955) |
Property and equipment, net | 1,168 | 1,636 |
Depreciation expense | 646 | 764 |
Furniture and fixtures | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment | $ 1,525 | 1,525 |
Estimated Useful Life (years) | 7 years | |
Office equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment | $ 1,077 | 1,077 |
Estimated Useful Life (years) | 3 years | |
Equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment | $ 4,012 | 3,834 |
Estimated Useful Life (years) | 7 years | |
Leasehold improvements | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment | $ 1,155 | $ 1,155 |
Estimated Useful Life (years) | 2 years |
Balance Sheet Accounts - Prepai
Balance Sheet Accounts - Prepaid Expenses and Other Current Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Balance Sheet Related Disclosures [Abstract] | ||
Advances to commercial manufacturers | $ 5,464 | $ 2,354 |
Prepaid FDA user fee and advances to CROs | 3,022 | 1,108 |
Prepaid insurance | 258 | 196 |
Prepaid income taxes | 90 | 1,173 |
Prepaid R&D | 106 | 0 |
Convertible promissory note, net | 0 | 5,312 |
Other Receivables | 1,001 | 347 |
All other | 3,259 | 1,400 |
Total Prepaid expenses and other current assets | $ 13,200 | $ 11,890 |
Balance Sheet Accounts - Accrue
Balance Sheet Accounts - Accrued Expenses and Other Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Balance Sheet Related Disclosures [Abstract] | ||
Royalties payable to commercial partners | $ 7,205 | $ 5,085 |
Accrued research & development | 1,549 | 4,100 |
Accrued professional fees | 5,541 | 2,013 |
Accrued salary and other compensation | 5,293 | 8,466 |
Accrued product sales reserves | 33,000 | 4,390 |
Current portion of lease liability | $ 1,534 | $ 1,309 |
Operating Lease, Liability, Current, Statement of Financial Position [Extensible Enumeration] | Total Accrued expenses and other liabilities | Total Accrued expenses and other liabilities |
Inventory received but not invoiced | $ 6,779 | $ 6,177 |
Income taxes payable | 5,182 | 0 |
Forward liability related to Enalare | 4,063 | 0 |
PEMFEXY royalty buy-down payable | 15,000 | 0 |
All other | 698 | 798 |
Total Accrued expenses and other liabilities | $ 85,844 | $ 32,338 |
Balance Sheet Accounts - Narrat
Balance Sheet Accounts - Narrative (Details) | Dec. 31, 2022 |
Balance Sheet Related Disclosures [Abstract] | |
Lessee, operating lease, remaining lease term | 2 years |
Lessee, operating lease, renewal term | 5 years |
Balance Sheet Accounts - Lease
Balance Sheet Accounts - Lease Related Disclosures (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Balance Sheet Related Disclosures [Abstract] | |||
Operating lease cost | $ 1,507 | $ 1,407 | $ 1,323 |
Total lease cost | 1,507 | 1,407 | |
Cash paid for amounts included in the measurement of lease liabilities | |||
Operating cash flows for operating leases | 1,507 | 1,407 | |
Right-of-use assets obtained in exchange for new operating lease liabilities | $ 0 | $ 270 | $ 855 |
Weighted-average remaining lease term - operating leases | 2 years 1 month 6 days | 3 years 1 month 6 days | |
Weighted-average discount rate - operating leases | 6% | 6% |
Balance Sheet Accounts - Future
Balance Sheet Accounts - Future Minimum Lease Payments (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Balance Sheet Classification as of December 31, 2022 | ||
Current lease liabilities (included with Accrued expenses and other liabilities) | $ 1,534 | $ 1,309 |
Operating Lease, Liability, Current, Statement of Financial Position [Extensible Enumeration] | Accrued Liabilities, Current | Accrued Liabilities, Current |
Long-term lease liabilities (included with Other long-term liabilities) | $ 1,508 | |
Operating Lease, Liability, Noncurrent, Statement of Financial Position [Extensible Enumeration] | Other long-term liabilities | |
Total lease liabilities | $ 3,042 |
Debt - Narrative (Details)
Debt - Narrative (Details) € in Millions | 3 Months Ended | 11 Months Ended | 12 Months Ended | 25 Months Ended | |||
Nov. 01, 2022 USD ($) | Nov. 08, 2019 USD ($) | Sep. 30, 2022 USD ($) | Sep. 30, 2023 USD ($) | Dec. 31, 2022 USD ($) | Oct. 31, 2025 USD ($) | Jun. 09, 2022 EUR (€) | |
Short-term Debt [Line Items] | |||||||
Installment payment amount | $ 6,250,000 | ||||||
Unamortized deferred debt issuance cost | $ 1,300,000 | ||||||
Revolving Credit Facility | |||||||
Short-term Debt [Line Items] | |||||||
Proceeds from line of credit | $ 15,000,000 | ||||||
Third Amended and Restated Credit Agreement | |||||||
Short-term Debt [Line Items] | |||||||
Proceeds from line of credit | $ 35,400,000 | ||||||
Third Amended and Restated Credit Agreement | Revolving Credit Facility | |||||||
Short-term Debt [Line Items] | |||||||
Long-term line of credit | 15,000,000 | ||||||
Third Amended and Restated Credit Agreement | Line of Credit | |||||||
Short-term Debt [Line Items] | |||||||
Maximum borrowing capacity | $ 50,000,000 | ||||||
Third Amended and Restated Credit Agreement | Line of Credit | Minimum | |||||||
Short-term Debt [Line Items] | |||||||
Line of credit facility, commitment fee (as a percent) | 0.38% | ||||||
Third Amended and Restated Credit Agreement | Line of Credit | Minimum | Secured Overnight Financing Rate (SOFR) | |||||||
Short-term Debt [Line Items] | |||||||
Variable interest rate spread (as a percent) | 2.50% | ||||||
Third Amended and Restated Credit Agreement | Line of Credit | Minimum | New York Federal Reserve Bank (NYFRB) | |||||||
Short-term Debt [Line Items] | |||||||
Variable interest rate spread (as a percent) | 1.50% | ||||||
Third Amended and Restated Credit Agreement | Line of Credit | Maximum | |||||||
Short-term Debt [Line Items] | |||||||
Line of credit facility, commitment fee (as a percent) | 0.48% | ||||||
Third Amended and Restated Credit Agreement | Line of Credit | Maximum | Secured Overnight Financing Rate (SOFR) | |||||||
Short-term Debt [Line Items] | |||||||
Variable interest rate spread (as a percent) | 3.25% | ||||||
Third Amended and Restated Credit Agreement | Line of Credit | Maximum | New York Federal Reserve Bank (NYFRB) | |||||||
Short-term Debt [Line Items] | |||||||
Variable interest rate spread (as a percent) | 2.25% | ||||||
Third Amended and Restated Credit Agreement | Line of Credit | Revolving Credit Facility | |||||||
Short-term Debt [Line Items] | |||||||
Maximum borrowing capacity | $ 100,000,000 | ||||||
Long-term line of credit | 15,000,000 | ||||||
Third Amended and Restated Credit Agreement | 2022 Term Loan | |||||||
Short-term Debt [Line Items] | |||||||
Long-term line of credit | $ 50,000,000 | ||||||
Third Amended and Restated Credit Agreement | 2022 Term Loan | Subsequent event | |||||||
Short-term Debt [Line Items] | |||||||
Installment payment amount | $ 1,250,000 | $ 2,500,000 | |||||
2022 Term Loan | Line of Credit | Secured Debt | |||||||
Short-term Debt [Line Items] | |||||||
Face amount | € | € 25 | ||||||
2022 Term Loan, Tranche A | Line of Credit | Secured Debt | |||||||
Short-term Debt [Line Items] | |||||||
Stated interest rate (as a percent) | 900% | ||||||
2022 Term Loan, Tranche B | Line of Credit | Secured Debt | |||||||
Short-term Debt [Line Items] | |||||||
Stated interest rate (as a percent) | 900% | ||||||
Second Amended and Restated Credit Agreement | London Interbank Offered Rate (LIBOR) | |||||||
Short-term Debt [Line Items] | |||||||
Variable interest rate spread (as a percent) | 1% | ||||||
Second Amended and Restated Credit Agreement | Revolving Credit Facility | |||||||
Short-term Debt [Line Items] | |||||||
Maximum borrowing capacity | $ 110,000,000 | ||||||
Second Amended and Restated Credit Agreement | Line of Credit | |||||||
Short-term Debt [Line Items] | |||||||
Proceeds from line of credit | $ 40,000,000 | ||||||
Amendment Credit Agreement | Minimum | |||||||
Short-term Debt [Line Items] | |||||||
Line of credit facility, commitment fee (as a percent) | 0.35% | ||||||
Amendment Credit Agreement | Minimum | London Interbank Offered Rate (LIBOR) | |||||||
Short-term Debt [Line Items] | |||||||
Variable interest rate spread (as a percent) | 2.25% | ||||||
Amendment Credit Agreement | Minimum | Prime Rate | |||||||
Short-term Debt [Line Items] | |||||||
Variable interest rate spread (as a percent) | 1.25% | ||||||
Amendment Credit Agreement | Maximum | |||||||
Short-term Debt [Line Items] | |||||||
Line of credit facility, commitment fee (as a percent) | 0.45% | ||||||
Amendment Credit Agreement | Maximum | London Interbank Offered Rate (LIBOR) | |||||||
Short-term Debt [Line Items] | |||||||
Variable interest rate spread (as a percent) | 3% | ||||||
Amendment Credit Agreement | Maximum | Prime Rate | |||||||
Short-term Debt [Line Items] | |||||||
Variable interest rate spread (as a percent) | 2% |
Debt - Schedule of Debt Maturit
Debt - Schedule of Debt Maturities (Details) $ in Thousands | Dec. 31, 2022 USD ($) |
Debt Disclosure [Abstract] | |
2023 | $ 6,250 |
2024 | 10,000 |
2025 | 47,500 |
Total | $ 63,750 |
Common Stock and Stock-Based _3
Common Stock and Stock-Based Compensation - Narrative (Details) | 3 Months Ended | 12 Months Ended | 17 Months Ended | 77 Months Ended | ||||||
Sep. 24, 2020 USD ($) $ / shares shares | Aug. 04, 2015 shares | Mar. 31, 2022 $ / shares shares | Mar. 31, 2021 milestone $ / shares shares | Dec. 31, 2022 USD ($) $ / shares shares | Dec. 31, 2021 USD ($) $ / shares shares | Dec. 31, 2020 USD ($) $ / shares shares | Mar. 17, 2020 USD ($) | Dec. 31, 2022 USD ($) shares | Sep. 23, 2020 USD ($) | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Payments to repurchase stock | $ 18,004,000 | $ 21,213,000 | $ 34,999,000 | |||||||
Fair value adjustments on settled accelerated share repurchase agreement | $ 0 | $ 0 | $ 2,962,000 | |||||||
Shares of common stock repurchased (in shares) | shares | 441,108 | 429,446 | 774,489 | |||||||
Award vesting period | 4 years | |||||||||
Number of shares available for grant (in shares) | shares | 1,934,193 | 1,934,193 | ||||||||
Weighted-average grant-date fair value of options granted (in dollars per share) | $ / shares | $ 20.49 | $ 23.62 | $ 28.98 | |||||||
Unrecognized compensation cost | $ 4,900,000 | $ 4,900,000 | ||||||||
Total intrinsic value of options exercised | $ 1,700,000 | |||||||||
Weighted average contractual terms of options outstanding | 5 years | 5 years 2 months 12 days | 6 years 1 month 6 days | |||||||
Aggregate pre-tax intrinsic value of options outstanding | $ 2,500,000 | $ 13,800,000 | $ 11,600,000 | 2,500,000 | ||||||
Common stock | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Share-based payment award, number of additional shares authorized (in shares) | shares | 500,000 | |||||||||
Options | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Unrecognized compensation cost expense term | 1 year 9 months 18 days | |||||||||
Expected volatility | 54.89% | |||||||||
Expected dividend yield | 0% | 0% | 0% | |||||||
Options | Minimum | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Expected term (in years) | 5 years 6 months | 5 years 6 months | 5 years 6 months | |||||||
Options | Maximum | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Expected term (in years) | 6 years 29 days | 6 years 29 days | 6 years 29 days | |||||||
RSU | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Unrecognized compensation cost expense term | 2 years 6 months | |||||||||
Unrecognized compensation cost | $ 7,600,000 | 7,600,000 | ||||||||
Expired (in shares) | shares | 38,995 | 76,167 | ||||||||
Granted (in shares) | shares | 148,000 | 106,600 | ||||||||
Weighted average grant date fair value (in dollars per share) | $ / shares | $ 47.75 | $ 48.55 | ||||||||
PSU | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Expired (in shares) | shares | 97,750 | 46,400 | 119,450 | |||||||
Granted (in shares) | shares | 228,200 | 159,000 | ||||||||
Weighted average grant date fair value (in dollars per share) | $ / shares | $ 63.93 | $ 62.94 | ||||||||
Risk free interest rate | 1.60% | 0.18% | ||||||||
Expected volatility | 41% | 44% | ||||||||
Expected term (in years) | 3 years | 3 years | ||||||||
Expected dividend yield | 0% | 0% | ||||||||
PSU | S&P Biotechnology | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Granted (in shares) | shares | 228,200 | 99,500 | ||||||||
Weighted average grant date fair value (in dollars per share) | $ / shares | $ 71.09 | |||||||||
PSU | S&P Biotechnology | Chief Executive Officer | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Weighted average grant date fair value (in dollars per share) | $ / shares | $ 70.45 | |||||||||
PSU | S&P Biotechnology | Other Executives | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Weighted average grant date fair value (in dollars per share) | $ / shares | $ 58.43 | |||||||||
Milestone Performance-Based Stock Units | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Granted (in shares) | shares | 59,500 | |||||||||
Weighted average grant date fair value (in dollars per share) | $ / shares | $ 49.32 | |||||||||
Number of milestones | milestone | 1 | |||||||||
Number of milestones required to be met | milestone | 3 | |||||||||
Expiration period | 3 years | |||||||||
Expected achievement rate | 0% | |||||||||
Milestone Performance-Based Stock Units | Minimum | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Award vesting percentage of target number granted | 0% | |||||||||
Milestone Performance-Based Stock Units | Maximum | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Award vesting percentage of target number granted | 200% | |||||||||
March 2020 Plan | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Stock repurchase program, authorized amount | $ 160,000,000 | |||||||||
Accelerated share repurchases, authorized amount | $ 25,000,000 | |||||||||
Accelerated share repurchases, payment | $ (25,000,000) | |||||||||
Accelerated share repurchases, shares received (in shares) | shares | 550,623 | |||||||||
Accelerated share repurchases, initial price paid per share (in dollars per share) | $ / shares | $ 45.40 | |||||||||
Fair value adjustments on settled accelerated share repurchase agreement | $ 3,000,000 | |||||||||
October 2018 Plan | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Payments to repurchase stock | $ 68,000,000 | |||||||||
Accelerated Share Repurchase | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Payments to repurchase stock | $ 246,100,000 | |||||||||
Shares of common stock repurchased (in shares) | shares | 4,552,730 |
Common Stock and Stock-Based _4
Common Stock and Stock-Based Compensation - Schedule of Common Stock Repurchase (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Share-Based Payment Arrangement [Abstract] | |||
Shares of common stock repurchased (in shares) | 441,108 | 429,446 | 774,489 |
Cash paid for repurchases of common stock | $ 18,004 | $ 21,213 | $ 34,999 |
Common Stock and Stock-Based _5
Common Stock and Stock-Based Compensation - Fair Value of Share Options Granted (Details) - Options | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Risk-free interest rate, minimum | 1.47% | 0.51% | 0.37% |
Risk-free interest rate, maximum | 4.30% | 1.26% | 1.65% |
Volatility, minimum | 45.59% | 52.87% | |
Volatility | 54.89% | ||
Volatility, maximum | 51.31% | 60.02% | |
Expected dividend yield | 0% | 0% | 0% |
Minimum | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Expected term (in years) | 5 years 6 months | 5 years 6 months | 5 years 6 months |
Maximum | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Expected term (in years) | 6 years 29 days | 6 years 29 days | 6 years 29 days |
Common Stock and Stock-Based _6
Common Stock and Stock-Based Compensation - Share-based Compensation, Options (Details) - $ / shares | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding [Roll Forward] | |||
Beginning balance (in shares) | 2,814,878 | 3,331,890 | |
Granted (in shares) | 139,700 | 114,000 | |
Exercised (in shares) | (91,255) | (122,847) | |
Forfeited or expired (in shares) | (437,490) | (508,165) | |
Ending balance (in shares) | 2,425,833 | 2,814,878 | 3,331,890 |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Exercise Price [Roll Forward] | |||
Beginning balance (in dollars per share) | $ 58.51 | $ 59.20 | |
Granted (in dollars per share) | 44.15 | 46.74 | |
Exercised (in dollars per share) | 25.74 | 27.64 | |
Forfeited or expired (in dollars per share) | 62.89 | 62 | |
Ending balance (in dollars per share) | $ 57.51 | $ 58.51 | $ 59.20 |
Non- Exercisable options outstanding (in shares) | 310,622 | 472,916 | 1,028,142 |
Exercisable options outstanding (in shares) | 2,115,211 | 2,341,962 | 2,303,748 |
Common Stock and Stock-Based _7
Common Stock and Stock-Based Compensation - Schedule of Restricted and Phantom Stock Unit Activity (Details) - $ / shares | 3 Months Ended | 12 Months Ended | |
Mar. 31, 2021 | Dec. 31, 2022 | Dec. 31, 2021 | |
RSU | |||
Number of Restricted Stock Units | |||
Beginning balance (in shares) | 328,396 | 263,306 | 328,396 |
Granted (in shares) | 148,000 | 106,600 | |
Vested (in shares) | (103,148) | (95,523) | |
Forfeited (in shares) | (38,995) | (76,167) | |
Ending balance (in shares) | 269,163 | 263,306 | |
Weighted Average Grant Date Fair Value (Per Share) | |||
Beginning balance (in dollars per share) | $ 53.09 | $ 51.77 | $ 53.09 |
Granted (in dollars per share) | 47.75 | 48.55 | |
Vested (in dollars per share) | 51.39 | 52.26 | |
Forfeited (in dollars per share) | 50.57 | 52.29 | |
Ending balance (in dollars per share) | $ 49.88 | $ 51.77 | |
PSU | |||
Number of Restricted Stock Units | |||
Beginning balance (in shares) | 97,750 | 137,300 | 97,750 |
Granted (in shares) | 228,200 | 159,000 | |
Vested (in shares) | 0 | 0 | |
Forfeited (in shares) | (97,750) | (46,400) | (119,450) |
Ending balance (in shares) | 319,100 | 137,300 | |
Weighted Average Grant Date Fair Value (Per Share) | |||
Beginning balance (in dollars per share) | $ 90.19 | $ 63.24 | $ 90.19 |
Granted (in dollars per share) | 63.93 | 62.94 | |
Vested (in dollars per share) | 0 | 0 | |
Forfeited (in dollars per share) | 59.27 | 84.90 | |
Ending balance (in dollars per share) | $ 63.96 | $ 63.24 |
Common Stock and Stock-Based _8
Common Stock and Stock-Based Compensation - Schedule of Share-based Compensation Cost (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share-based compensation expense | $ 16,451 | $ 19,555 | $ 24,756 |
Options | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share-based compensation expense | 6,714 | 11,521 | 17,694 |
PSU | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share-based compensation expense | 4,665 | 2,729 | 1,635 |
RSU | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share-based compensation expense | 5,072 | 5,305 | 5,427 |
Selling, general and administrative | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share-based compensation expense | 14,001 | 16,873 | 22,074 |
Research and development | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share-based compensation expense | $ 2,450 | $ 2,682 | $ 2,682 |
Income Taxes - Schedule of Comp
Income Taxes - Schedule of Components of Income Tax Expense (Benefit) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Current: | |||
Federal | $ 30,933 | $ 6,912 | $ 10,140 |
State | 3,181 | 785 | 2,059 |
Total | 34,114 | 7,697 | 12,199 |
Deferred: | |||
Federal | (7,607) | (3,030) | (1,227) |
State | (740) | (588) | (284) |
Foreign | 24 | 0 | 0 |
Total | (8,323) | (3,618) | (1,511) |
Provision for income taxes | $ 25,791 | $ 4,079 | $ 10,688 |
Income Taxes - Schedule of Effe
Income Taxes - Schedule of Effective Income Tax Rate Reconciliation (Details) | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | |||
U.S. Federal statutory tax rate | 21% | 21% | 21% |
State income taxes, net of federal benefit | 3% | (1.00%) | 6% |
Tax effect on stock option exercises, net of forfeitures | 2% | (44.00%) | 4% |
R&D tax credits and Orphan Drug credits | (1.00%) | 31% | (2.00%) |
Limitation on executive compensation | 3% | (60.00%) | 9% |
Change in valuation allowance | 13% | (40.00%) | 9% |
Transaction costs | 3% | 0% | 0% |
Foreign rate differential | (2.00%) | 4% | (1.00%) |
Other | 0% | (1.00%) | 1% |
Effective tax rate | 42% | (90.00%) | 47% |
Income Taxes - Schedule of Defe
Income Taxes - Schedule of Deferred Tax Assets and Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Deferred tax assets | ||
Net operating loss carryforward | $ 46,996 | $ 1,563 |
Stock based compensation | 9,875 | 10,405 |
Other asset - equity investment with readily determined fair value | 4,197 | 3,190 |
Inventories | 3,405 | 2,123 |
Employee-related expenses | 205 | 1,240 |
Intangible assets | 4,559 | 4,207 |
Right-of-use liability | 688 | 962 |
R&D tax credit carryforwards | 471 | 329 |
Capitalized R&D | 7,579 | 0 |
Other | 3,659 | 1,489 |
Total deferred tax assets | 81,634 | 25,508 |
Deferred tax liabilities | ||
Installment sale - Malta | 484 | 485 |
Prepaid expenses | 59 | 45 |
Fixed assets | 255 | 300 |
Lease liability | 648 | 921 |
Intangible assets | 18,530 | 0 |
Inventories | 2,981 | 0 |
Other | 247 | 0 |
Total deferred tax liabilities | 23,204 | 1,751 |
Valuation allowance | (35,101) | (4,959) |
Net deferred tax assets | $ 23,329 | $ 18,798 |
Income Taxes - Narrative (Detai
Income Taxes - Narrative (Details) | 12 Months Ended | |
Dec. 31, 2022 USD ($) jurisdiction | Dec. 31, 2021 USD ($) | |
Tax Credit Carryforward [Line Items] | ||
Number of tax jurisdictions currently auditing the company | jurisdiction | 3 | |
Unrecognized tax benefits | $ 0 | |
Deferred tax assets, operating loss carryforwards, foreign | 5,500,000 | |
Net operating loss carryforward | 46,996,000 | $ 1,563,000 |
Valuation allowance for deferred tax assets increased | 30,100,000 | |
Acacia Pharma Inc | ||
Tax Credit Carryforward [Line Items] | ||
Deferred tax assets, operating loss carryforwards, foreign | 12,000,000 | |
Net operating loss carryforward | 6,500,000 | |
Acacia Pharma Group | ||
Tax Credit Carryforward [Line Items] | ||
Net operating loss carryforward | $ 167,000,000 |
License and Collaboration Agr_2
License and Collaboration Agreements (Details) - USD ($) | 12 Months Ended | ||||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | Aug. 31, 2021 | Jan. 07, 2020 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Fair value gain (loss) on equity investment | $ (4,457,000) | $ (6,170,000) | $ (5,300,000) | ||
Combioxin | Collaborative Arrangement, Transaction with Party to Collaborative Arrangement | |||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Collaborative arrangement, rights and obligations, upfront payment | $ 10,000,000 | ||||
Collaborative arrangement, rights and obligations, maximum aggregate milestone payments | 105,000,000 | ||||
AOP Orphan Pharmaceuticals GmbH | Collaborative Arrangement, Transaction with Party to Collaborative Arrangement | |||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Collaborative arrangement, rights and obligations, upfront payment | 5,000,000 | ||||
Collaborative arrangement, rights and obligations, maximum aggregate milestone payments | $ 25,000,000 | ||||
Tyme | Collaborative Arrangement, Transaction with Party to Collaborative Arrangement | |||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Co-promotion agreement, percentage of promotional sales effort responsible for | 25% | ||||
Co-promotion agreement, percentage of net revenue receivable | 15% | ||||
Co-promotion agreement, percentage of net revenue receivable due to collaborator | 85% | ||||
Co-promotion agreement, right to repurchase, amount | $ 200,000,000 | ||||
Fair value gain (loss) on equity investment | $ (4,500,000) | $ (6,200,000) | $ (5,300,000) |
Commitments (Details)
Commitments (Details) - USD ($) $ in Thousands | 12 Months Ended | |||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | Aug. 31, 2022 | |
Long-Term Purchase Commitment [Line Items] | ||||
Operating lease cost | $ 1,507 | $ 1,407 | $ 1,323 | |
Purchase obligation | 87,501 | |||
Operating Leases | ||||
Total | 3,207 | |||
2023 | 1,672 | |||
2024 | 1,122 | |||
2025 | 413 | |||
Beyond | 0 | |||
Less: imputed interest | (165) | |||
Total lease liabilities | 3,042 | |||
Credit facility and Term loans (2) | ||||
Total | 63,750 | |||
2023 | 6,250 | |||
2024 | 10,000 | |||
2025 | 47,500 | |||
Required contractual investment in Enalare | ||||
Total | 12,500 | |||
2023 | 12,500 | |||
2024 | 0 | |||
2025 | 0 | |||
Beyond | 0 | |||
Purchase obligations | ||||
Total | 87,501 | |||
2023 | 87,501 | |||
2024 | 0 | |||
2025 | 0 | |||
Beyond | 0 | |||
Total obligations | ||||
Total | 166,958 | |||
2023 | 107,923 | |||
2024 | 11,122 | |||
2025 | 47,913 | |||
Beyond | 0 | |||
Line of Credit | 2022 Term Loan | ||||
Credit facility and Term loans (2) | ||||
Total | 63,750 | |||
2023 | 6,250 | |||
2024 | 10,000 | |||
2025 | 47,500 | |||
Beyond | 0 | |||
Collaborative Arrangement | ||||
Long-Term Purchase Commitment [Line Items] | ||||
Purchase obligation | 87,500 | |||
Purchase obligations | ||||
Total | $ 87,500 | |||
Investment in Enalare Therapeutics, Inc. | ||||
Long-Term Purchase Commitment [Line Items] | ||||
Investments | $ 12,500 |
Investment in Enalare Therape_3
Investment in Enalare Therapeutics Inc. - Narratives (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Aug. 08, 2022 | Dec. 31, 2021 |
Schedule of Equity Method Investments [Line Items] | |||
Acquisition rights of Enalare Therapeutics, Inc. | $ 8,125 | ||
Forward Liability | 4,063 | ||
Investment in contractual obligation within another six months | 12,500 | ||
Enlare Therapeutics Inc. | |||
Schedule of Equity Method Investments [Line Items] | |||
Committed equity investment | $ 30,000 | ||
Equity investment | 12,500 | $ 0 | |
Investment in Enalare Therapeutics, Inc. | |||
Schedule of Equity Method Investments [Line Items] | |||
Investments | 8,438 | 0 | |
Acquisition rights of Enalare Therapeutics, Inc. | 8,125 | 0 | |
Forward Liability | $ 4,063 | $ 0 |
Investment in Enalare Therape_4
Investment in Enalare Therapeutics Inc. - Schedule of Equity Method Investments (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2022 USD ($) | |
Equity Method Investments [Roll Forward] | |
Acquisition Rights (Other assets), ending balance | $ 8,125 |
Forward Liability (Accrued expenses and other liabilities, ending balance | (4,063) |
Investment in Enalare Therapeutics, Inc. | |
Equity Method Investments [Roll Forward] | |
Non-RDFV Investment (Other assets), beginning balance | 0 |
Non-RDFV Investment (Other assets), additions during period | 8,438 |
Non-RDFV Investment (Other assets), ending balance | 8,438 |
Acquisition Rights (Other assets), beginning balance | 0 |
Acquisition Rights (Other assets), additions during period | 8,125 |
Acquisition Rights (Other assets), ending balance | 8,125 |
Forward Liability (Accrued expenses and other liabilities, beginning balance | 0 |
Forward Liability (Accrued expenses and other liabilities, additions during period | (4,063) |
Forward Liability (Accrued expenses and other liabilities, ending balance | (4,063) |
Additions during period | 12,500 |
Enlare Therapeutics Inc. | |
Equity Method Investments [Roll Forward] | |
Beginning balance as of January 1, 2022 | 0 |
Adjustments | 0 |
Ending balance as of December 31, 2022 | $ 12,500 |
Intangible Assets, Net - Schedu
Intangible Assets, Net - Schedule of Intangible Assets (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Finite-Lived Intangible Assets [Line Items] | ||
Gross Carrying Amount | $ 134,783 | $ 23,850 |
Accumulated Amortization | (16,456) | (13,179) |
Accumulated Impairment Charges | 0 | 0 |
Net Book Value | $ 118,327 | $ 10,671 |
Barhemsys intangible | ||
Finite-Lived Intangible Assets [Line Items] | ||
Useful Life (In Years) | 9 years | |
Gross Carrying Amount | $ 70,319 | |
Accumulated Amortization | (4,462) | |
Accumulated Impairment Charges | 0 | |
Net Book Value | $ 65,857 | |
Byfavo intangible | ||
Finite-Lived Intangible Assets [Line Items] | ||
Useful Life (In Years) | 9 years | |
Gross Carrying Amount | $ 33,714 | |
Accumulated Amortization | (1,989) | |
Accumulated Impairment Charges | 0 | |
Net Book Value | $ 31,725 | |
Ryanodex intangible | ||
Finite-Lived Intangible Assets [Line Items] | ||
Useful Life (In Years) | 9 years | 9 years |
Gross Carrying Amount | $ 15,000 | $ 15,000 |
Accumulated Amortization | (7,402) | (5,079) |
Accumulated Impairment Charges | 0 | 0 |
Net Book Value | $ 7,598 | $ 9,921 |
PEMFEXY intangible | ||
Finite-Lived Intangible Assets [Line Items] | ||
Useful Life (In Years) | 2 years | |
Gross Carrying Amount | $ 15,000 | |
Accumulated Amortization | (1,888) | |
Accumulated Impairment Charges | 0 | |
Net Book Value | $ 13,112 | |
Vasopressin Milestone | ||
Finite-Lived Intangible Assets [Line Items] | ||
Useful Life (In Years) | 1 year | 1 year |
Gross Carrying Amount | $ 750 | $ 750 |
Accumulated Amortization | (715) | 0 |
Accumulated Impairment Charges | 0 | 0 |
Net Book Value | $ 35 | $ 750 |
Developed technology | ||
Finite-Lived Intangible Assets [Line Items] | ||
Useful Life (In Years) | 5 years | |
Gross Carrying Amount | $ 8,100 | |
Accumulated Amortization | (8,100) | |
Accumulated Impairment Charges | 0 | |
Net Book Value | $ 0 |
Intangible Assets, Net - Narrat
Intangible Assets, Net - Narrative (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Change in Accounting Estimate [Line Items] | |||
Amortization expense of intangible assets | $ 11,378 | $ 2,996 | $ 2,666 |
Intangible assets | 118,327 | 10,671 | |
Ryanodex intangible | |||
Change in Accounting Estimate [Line Items] | |||
Intangible assets | $ 7,598 | 9,921 | |
Intangible Assets, Amortization Period | |||
Change in Accounting Estimate [Line Items] | |||
Amortization expense of intangible assets | $ 400 |
Intangible Assets, Net - Sche_2
Intangible Assets, Net - Schedule of Future Amortization Expense (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Goodwill and Intangible Assets Disclosure [Abstract] | ||
2023 | $ 21,916 | |
2024 | 19,770 | |
2025 | 13,908 | |
2026 | 11,606 | |
2027 | 11,606 | |
Thereafter | 39,521 | |
Net Book Value | $ 118,327 | $ 10,671 |
Legal Proceedings (Details)
Legal Proceedings (Details) - Pending Litigation $ in Millions | Feb. 28, 2023 USD ($) | Jan. 23, 2023 USD ($) | Dec. 20, 2019 patent |
Curia Demand for Arbitration | Subsequent event | |||
Loss Contingencies [Line Items] | |||
Damages sought | $ 76.7 | ||
Curia's Claims in Arbitration | Subsequent event | |||
Loss Contingencies [Line Items] | |||
Damages sought | $ 4.2 | ||
Par Pharmaceutical, Inc. et al. v. Eagle Pharmaceuticals, Inc. (Vasopressin) | |||
Loss Contingencies [Line Items] | |||
Number of patents, claims dismissed | patent | 3 |
Convertible Promissory Note (De
Convertible Promissory Note (Details) - USD ($) | 3 Months Ended | 12 Months Ended | |||
Mar. 31, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | Mar. 31, 2021 | |
Debt Securities, Available-for-sale, Allowance for Credit Loss [Roll Forward] | |||||
Embedded Derivative, beginning balance | $ 962,000 | $ 962,000 | |||
Total in Other Current Assets, beginning balance | $ 5,312,000 | 5,312,000 | |||
Fair Value Adjustments to the note | 94,000 | $ (94,000) | $ 0 | ||
Estimated Credit Loss | 0 | (758,000) | 0 | ||
Embedded Derivative, ending balance | 962,000 | ||||
Total in Other Current Assets, ending balance | 0 | 5,312,000 | |||
Convertible Promissory Note | |||||
Debt Securities, Available-for-sale [Line Items] | |||||
Debt securities, available-for-sale | $ 5,000,000 | ||||
Stated interest rate (as a percent) | 8% | ||||
Credit agreement, term | 18 months | ||||
Debt Securities, Available-for-sale, Allowance for Credit Loss [Roll Forward] | |||||
Fair value of the note, beginning balance | $ 4,906,000 | 4,906,000 | 5,000,000 | ||
Discount on the note, beginning balance | (127,000) | (127,000) | (276,000) | ||
Estimated Credit Loss, beginning balance | (758,000) | (758,000) | 0 | ||
Convertible Promissory Note, net, beginning balance | 4,021,000 | 4,021,000 | 4,724,000 | ||
Embedded Derivative, beginning balance | 962,000 | 962,000 | 276,000 | ||
Interest Receivable, beginning balance | 329,000 | 329,000 | 0 | ||
Total in Other Current Assets, beginning balance | 5,312,000 | 5,312,000 | 5,000,000 | ||
Fair Value Adjustments to the note | (4,906,000) | (94,000) | |||
Accretion of Discount | 127,000 | 149,000 | |||
Interest Income | 0 | 329,000 | |||
Fair Value Adjustment to Embedded Derivative | (962,000) | 686,000 | |||
Fair value of the note, ending balance | 0 | 4,906,000 | 5,000,000 | ||
Discount on the note, ending balance | 0 | (127,000) | (276,000) | ||
Estimated Credit Loss, ending balance | 0 | (758,000) | 0 | ||
Convertible Promissory Note, net, ending balance | 0 | 4,021,000 | 4,724,000 | ||
Embedded Derivative, ending balance | 0 | 962,000 | 276,000 | ||
Interest Receivable, ending balance | 0 | 329,000 | 0 | ||
Total in Other Current Assets, ending balance | 5,312,000 | $ 5,000,000 | |||
Convertible Promissory Note | Other Current Assets | |||||
Debt Securities, Available-for-sale, Allowance for Credit Loss [Roll Forward] | |||||
Total in Other Current Assets, beginning balance | $ 5,312,000 | 5,312,000 | |||
Fair Value Adjustments to the note | (4,906,000) | ||||
Accretion of Discount | 127,000 | ||||
Estimated Credit Loss | 429,000 | (758,000) | |||
Interest Income | 0 | ||||
Fair Value Adjustment to Embedded Derivative | (962,000) | ||||
Total in Other Current Assets, ending balance | 0 | 5,312,000 | |||
Convertible Promissory Note | Reclassification, Other | |||||
Debt Securities, Available-for-sale, Allowance for Credit Loss [Roll Forward] | |||||
Estimated Credit Loss | (329,000) | 0 | |||
Convertible Promissory Note | Valuation, Estimated Credit Loss | |||||
Debt Securities, Available-for-sale, Allowance for Credit Loss [Roll Forward] | |||||
Estimated Credit Loss | 758,000 | (758,000) | |||
Convertible Promissory Note | Convertible Promissory Note, Net | |||||
Debt Securities, Available-for-sale, Allowance for Credit Loss [Roll Forward] | |||||
Estimated Credit Loss | $ 758,000 | $ (758,000) |
Business Acquisition - Narrativ
Business Acquisition - Narrative (Details) $ / shares in Units, $ in Thousands, € in Millions | 7 Months Ended | 12 Months Ended | |||
Jun. 09, 2022 USD ($) $ / shares shares | Jun. 09, 2022 EUR (€) shares | Dec. 31, 2022 USD ($) | Dec. 31, 2022 USD ($) | Dec. 31, 2021 USD ($) | |
Business Acquisition [Line Items] | |||||
Goodwill | $ 45,033 | $ 45,033 | $ 39,743 | ||
Acacia Pharma | |||||
Business Acquisition [Line Items] | |||||
Cash consideration | $ 76,708 | € 94.7 | |||
Cash consideration per share (in euros per share) | $ / shares | $ 0.90 | ||||
Number of shares issued in business acquisition (in shares) | shares | 516,024 | 516,024 | |||
Cash paid per acquiree share (in euros per share) | $ / shares | $ 0.68 | ||||
Number of company stock for each share of Acacia Pharma common stock converted (in shares) | shares | 0.0049 | 0.0049 | |||
Fair value of consideration | $ 100,353 | ||||
Goodwill | $ 3,315 | 5,291 | 5,291 | ||
Acquisition related expenses | $ 12,600 | ||||
Revenue from acquiree since acquisition | 1,600 | ||||
Loss from acquiree since acquisition | $ 15,800 |
Business Acquisition - Schedule
Business Acquisition - Schedule of Fair Value of Consideration (Details) - Jun. 09, 2022 - Acacia Pharma $ in Thousands, € in Millions | EUR (€) | USD ($) |
Business Acquisition [Line Items] | ||
Cash consideration | € 94.7 | $ 76,708 |
Fair value of consideration | 100,353 | |
Common stock | ||
Business Acquisition [Line Items] | ||
Fair value of Eagle common stock issued | $ 23,645 |
Business Acquisition - Prelimin
Business Acquisition - Preliminary Allocation of Purchase Price to Estimated Fair Values of Assets Acquired and Liabilities Assumed (Details) - USD ($) | 7 Months Ended | ||
Dec. 31, 2022 | Jun. 09, 2022 | Dec. 31, 2021 | |
Business Acquisition [Line Items] | |||
Goodwill | $ 45,033,000 | $ 39,743,000 | |
Acacia Pharma | |||
Business Acquisition [Line Items] | |||
Cash | 2,556,000 | $ 2,556,000 | |
Net working capital, excluding cash | (2,158,000) | (2,158,000) | |
Inventory | 17,548,000 | 26,942,000 | |
Measurement period adjustments, inventory | (9,394,000) | ||
Intangible assets | 108,000,000 | 104,000,000 | |
Measurement period adjustments, intangibles | 4,000,000 | ||
Debt | (26,659,000) | (28,503,000) | |
Measurement period adjustments, debt | 1,844,000 | ||
Deferred tax liability, net | (4,225,000) | (4,536,000) | |
Measurement period adjustments, deferred tax liabilities, net | 311,000 | ||
Fair value of net assets acquired | 95,062,000 | 98,301,000 | |
Measurement period adjustments, fair value of net assets acquired | (3,239,000) | ||
Goodwill | 5,291,000 | 3,315,000 | |
Measurement period adjustments, goodwill | 1,976,000 | ||
Fair value of assets acquired, including goodwill | 100,353,000 | $ 101,616,000 | |
Measurement Period Adjustments, Fair value of assets acquired, including goodwill | $ (1,263,000) |
Business Acquisition - Pro Form
Business Acquisition - Pro Forma Financial Information (Details) - Acacia Pharma - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Business Acquisition, Pro Forma Information, Nonrecurring Adjustment [Line Items] | ||
Total revenue | $ 317,792 | $ 172,709 |
Net income (loss) | $ 19,189 | $ (92,886) |